Should the Plastibell Be Removed Twenty- Four Hours After Circumcision?

SHOULD THE PLASTIBELL BE REMOVED TWENTY- FOUR HOURS AFTER CIRCUMCISION?

DR. SYLVESTER IKHISEMOJIE MBBS (BENIN).

OF THE PAEDIATRIC SURGERY UNIT, DEPARTMENT OF SURGERY LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS.

A DISSERTATION SUBMITTED TO

THE NATIONAL POSTGRADUATE MEDICAL COLLEGE OF NIGERIA IN PART FULFILMENT OF THE REQUIREMENTS FOR THE AWARD OF THE FELLOWSHIP OF THE MEDICAL COLLEGE IN SURGERY, FMCS.

MAY 2012

1 DEDICATION

This Dissertation is deservedly dedicated to

My Parents

For the uncompromising principles that guide their lives.

My Sisters

For the wonderful support they have been

And to My Family

For making everything worthwhile.

2 TABLE OF CONTENTS

Title … … … … … … … … … … … … i Dedication … … … … … … … … … … … ii Table of Contents… … … … … … … … … … iii Attestation… … … … … … … … … … … iv Acknowledgements… … … … … … … … … … v Definitions … … … … … … … … … … … vi Summary… … … … … … … … … … … … vii

Chapter One Introduction… … … … … … … … … … … 1 Statement of Problem… … … … … … … … … … 5 Justification… … … … … … … … … … … 6 Scope of the Study… … … … … … … … … … 7 Limitations of the Study… … … … … … … … … 8

Chapter Two Literature Review… … … … … … … … … … 9 Aims and Objectives of Study … … … … … … … … 25

Chapter Three Methodology… … … … … … … … … … … 26 Data Analysis… … … … … … … … … … … 40

Chapter Four Results… … … … … … … … … … … … 41

Chapter Five Discussion … … … … … … … … … … … 54

3 Conclusion … … … … … … … … … … … 58 Recommendations … … … … … … … … … … 59 References … … … … … … … … … … … 60 Proforma … … … … … … … … … … … 65 Appendix 1 … … … … … … … … … … … 66 Appendix 2 … … … … … … … … … … … 67

4 ATTESTATION

This is to certify that we have jointly supervised DR. SYLVESTER ONOFE IKHISEMOJIE on the dissertation titled ‘SHOULD THE PLASTIBELL BE REMOVED 24 HOURS

AFTER CIRCUMCISION?’

……………………………………. …………………………………. Christopher Bode. FMCS; FWACS B. O. Mofikoya. FWACS; FMCS Associate Professor/Consultant Paediatric Surgeon Consultant Plastic Surgeon

Date…………………… Date………………..

5 ACKNOWLEDGEMENTS

To Prof Chris Bode, I owe a huge debt of gratitude for mentoring and directing the bulk of this work. I am also greatly indebted to Dr Bolaji Mofikoya, Consultant Plastic Surgeon, for his invaluable supervisory role all through the duration of the study. My thanks go to Dr.

Adedapo Osinowo, and his wife who provided me with lots of materials and also proof-read some of my work. I wish also to thank Dr. Seyi Olajide for giving me the skeleton upon which I was able to build this work. To Dr. Adesoji Ademuyiwa, Consultant Paediatric

Surgeon, who constantly goaded me to complete this dissertation. I am deeply grateful. Dr.

Jibola Jeje and Dr. Bisi Ogunjimi, were also very encouraging. I wish also to thank Dr.

Ronke Desalu, consultant anaesthesiologist for all her contributions. I owe the completion of this study to you all.

Finally, I wish to acknowledge the remarkable family I have been blessed with. They endured my frequent absence from home. Their collective sacrifice was a constant reminder of the importance of completing this work.

6 DEFINITIONS

HIV: Human Immunodeficiency Virus.

AIDS: Acquired Immune Deficiency Syndrome.

LUTH: Lagos University Teaching Hospital.

GOMCO: Goldstein Manufacturing Company.

FLACC: Face Leg Activity Cry Consolability Test

PCV: Packed Cell Volume.

EMLA: Eutetic Mixture of Local Anaesthetic

SSI : Sample Size Index

7 SUMMARY

Although circumcision is the commonest surgical procedure carried out in male neonates using a variety of methods, complications still arise with the use of all the methods. In Africa and much of the Middle East, circumcision is widely practiced mainly for socio-cultural reasons and the rate is almost 100 percent whereas, in Western Europe and North America, circumcision rates have fallen in recent years. Most of the post-circumcision complications referred to the Lagos University Teaching Hospital, LUTH are related to the use of the Plastibell ring. Some of these procedures were performed by relatively low-skilled health- workers. Post-circumcision complications are seen more in areas of the world lacking in adequate health-care personnel. The Plastibell ring is popular among mothers in Lagos. Many of them have no knowledge of its fall-off time, what constitutes prolonged retention and what harm it can cause. Since both doctors and other health workers widely use the Plastibell ring, it became important to examine ways to reduce the complication rate from the use of this method.

This study also aimed to determine the benefits of the early removal of the Plastibell ring, or its ill-effects compared with the traditional delayed fall-off time of the device. It also compared the bleeding rates between subjects who underwent early removal of the Plastibell and a control group whose devices were left to fall off on their own.

A total of sixty consecutive male neonates were recruited for this study and all of them underwent circumcision with the Plastibell device. Thirty patients were assigned to the Subject Group, in whom the Plastibell ring was removed by the investigator at 24 hours while the other thirty constituted the Control Group whose Plastibell rings were allowed to fall off on their own. Both were selected by closed balloting.

The patients selected were aged between 7 and 28 days, with a mean age of 11.3 ± 5.3 days. The modal age was 8 days with 28 ( 46.7%) babies presenting for circumcision on that day. The age, weight and PCV of both the subjects and controls were comparable. There was minor haemorrhage in 3 of the 30 Subjects and in 1 of the 30 Controls (P = 0.3006). Similarly, wound infection rates were comparable between both groups with only 1 wound being infected among the Controls and none among the Subjects (P=1). In both groups, reported discomfort from circumcision was incomparable as there was no reliable, complete data. The mean duration of complete wound healing was 6.2 ± 0.8 days in the Subject Group

8 and 9.4 ± 1.7 days in the Control Group (p<0.005). The mean duration of wound healing was 7.8 ± 2.1 in the entire study group so that it took a significantly longer number of days to achieve complete wound healing in the Control Group. The fall-off time of the Plastibell ring in the Control Group ranged from 1-7 days with a mean of 4.6 ± 1.6 days. The modal day was Day 6 when 11 of the Plastibell rings fell off. This was statistically significantly prolonged when compared with the 1 day in which the devices in the Subject Group were removed.

In conclusion, early removal of the Plastibell at twenty-four hours following circumcision was not attended by any significant haemorrhage, infection or discomfort. Rather, it appeared to promote wound healing. These findings remain to be validated in a wider study. It is hereby recommended from this study that the Plastibell circumcision ring could be removed twenty-four hours after circumcision without significant complications.

CHAPTER ONE

INTRODUCTION

Circumcision, the partial or complete removal of the foreskin on the male genitalia, has been practiced for thousands of years and was initially thought to have originated in ancient Egypt as a means of marking male slaves1. It is now believed to have been copied from the

Babylonians or from the Negroes of West Africa, most probably the latter, which may be why it is a cultural practice in the two sub-regions2. However, there is evidence even from ancient civilizations that circumcision may have been practiced as early as 5000 BC1,2,3,4. The

Jews trace their ritual circumcisions to Abraham4,5,6. Since the days of Moses, it became a prerequisite for asserting the Jewish identity. This operation has been carried out for millennia for both religious and cultural reasons7,8,9. It is also widely practiced in North

America with about 1.3 million circumcisions in the United States in 1997, constituting 65 percent of all newborn males but less than the 90 percent circumcision rate reported a decade earlier10. It is much less practiced in Europe and seldom seen in the Indian sub-continent and

9 the Orient because Buddhism abhors bodily mutilation. In many other cultures, especially in

Africa, it has simply been a means of cultural identity and a rite of passage into manhood9,11.

It is the most common surgical operation carried out in new-born males worldwide and is universally practiced in the West African sub-region.

The medical indications for performing circumcisions are few and include such problems as phimosis, paraphimosis and recurrent balanitis. These indications constitute less than 1 percent of all circumcisions12,13,14. Advocates of this widely practiced procedure list a number of its advantages as increased levels of genital cleanliness, diminished rates of penile cancer, reduced incidence of cervical cancer among the partners of circumcised men14,15,16,17. Most recently, a reduced rate of heterogenous transmission of the Human Immunodeficiency Virus

(HIV), the virus which causes the Acquired Immune Deficiency Syndrome (AIDS) has been credited to routine male neonatal circumcision18,19. Opponents of circumcision cite the scant evidence in support of the claim that circumcised males are cleaner or healthier than the uncircumcised20. The British Paediatric Association16,17 recently issued an official statement which states that ‘even though evidence exists suggesting that there are certain health benefits deriving from circumcision, such benefits are not of a sufficiently general nature to recommend routine neonatal circumcision’. Those who anchor their arguments on health grounds may have a point, though, because the HIV/AIDS pandemic has shown that male circumcision might have an important role to play in halting the spread of the disease. It is now an established fact that HIV/AIDS is spread mainly through heterosexual activity and the majority of new cases in Africa support this view18,19,20,21. The membranous inner preputial skin of the glans penis is quite susceptible to invasion by micro-organisms and this is thought to be the portal of entry of these organisms into the human body. Consequently, circumcision is now believed to be an important component of HIV prevention efforts. Male

10 circumcision is consequently encouraged now in Central, East and South Africa as part of a wider effort to combat the disease21,22.

More than twenty different methods of circumcision have been described in the literature

from antiquity through the era of the Pharaohs in Egypt when the Isrealites were held in

captivity, right to the present day1,5,23,24. Not a single method is without complications and

this has led to continuous improvement of the old devices while new ones are being

developed25,26. The twin problems of haemorrhage and penile injuries have attracted the

most attention in the history of the development of the various devices and also in

developing modifications to the way in which the open circumcision method is performed.

In spite of these, no truly ideal method of circumcision has yet been developed27,28,29. Some

of the modern day circumcision devices include the Mogen clamp, the Gomco clamp and

the Plastibell26,29. Although an ideal circumcision method should do no harm to the

circumcised patient, the various methods of circumcision are associated with many

complications, especially in the hands of the untrained who perform the bulk of

circumcisions. Thus circumcision complication rates vary from 0.5-30 percent 30,31.

In Lagos, the Plastibell ring method is the most popular and, it is much demanded by

mothers of male neonates. This method, however, is the second most common cause of

circumcision related complications in Lagos8. The various types of complications seen are

haemorrhage, retention of the ring beyond the expected fall-off period and formation of

urethrocutaneous fistula. Haemorrhage occurs when the ring slips. The ring slips off for two

main reasons; due to the insertion of an oversized Plastibell and due to the application of an

unsafe knot when securing the device. Either of these technical miscues will cause

haemorrhage which sometimes requires blood transfusion and may cause mortality.

Retention of the ring commonly causes two problems; a urethrocutaneous fistula may result

11 because the urethra is subcutaneous ventrally and skin necrosis will expose it. Sometimes, gross penile oedema results from the retention of the ring. In such a circumstance, the ring is surgically removed. In some cases, the string is secured so tightly that it causes the distal end of the Plastibell to dig into the glans and exert pressure. This leads frequently to necrosis of the glans. The above complications arising from the use of the Plastibell show that all of them are preventable. If they can be prevented from occurring, why then do they still happen? If the device was removed after 24 hours, perhaps only haemorrhage might have occurred and the attending surgeon would be on hand to deal with that. Retention will not occur and neither will penile oedema, nor necrosis nor fistula formation. Consequently, early removal may be an important key in the prevention of these avoidable events. There is thus the need for further study into the use of this method to improve its outcome. This study therefore explored and re-examined the rationale behind the prolonged retention of the

Plastibell ring among circumcised newborn males in Lagos. It is because of these concerns that this question was posed and the study conducted.

STATEMENT OF PROBLEM

The Plastibell is the most popular circumcision method among mothers in Lagos as it is aggressively marketed by retailers of medical consumables and pharmacy shops. However, mothers have only heard of its supposed convenience but not of the hazards associated with its use. At the Lagos University Teaching Hospital, we have recorded many circumcision problems resulting from prolonged retention of the Plastibell ring and this study therefore sought to explore ways of reducing complications resulting from prolonged retention of the ring.

JUSTIFICATION

Bleeding, the commonest complication following circumcision, has been a driving force for most of the innovations seen in circumcision methods and it is an important reason for retaining the Plastibell ring until it falls off by itself. Retention, when prolonged however sometimes causes unacceptable complications such as penile necrosis, amputation and urethrocutaneous fistula. Ross had 60 years earlier, stated that the Ross ring (precursor of the modern day Plastibell) could be removed after 24 hours29 but this seems to have been forgotten by the medical community. A pilot study of 5 closely monitored babies showed results which were most encouraging when the Plastibell ring was removed 24 hours after circumcision. This study therefore challenges a long-held dogma which teaches prolonged retention of the Plastibell ring. Anecdotally, the Plastibell ring has even been known to fall off on the day after circumcision. Since this happens with no ill effects, that done in a controlled environment should be worthy of the effort. If this proves to be correct, many

14 complications resulting from prolonged retention of the Plastibell would be reduced to a minimum.

15 SCOPE OF THE STUDY

This study was designed to investigate the possibility of reducing the surgical burden and inherent complications from retaining the Plastibell ring for a longer period after haemostasis has been achieved. Therefore, this study explored the possibility of using a shortened period to obviate some of the complications associated with its use. The main outcome parameter is bleeding as a complication of early removal. The study was restricted to only neonates and therefore, it did not cover other complications of circumcision as seen in older children and adults. It also excluded later complications that possibly arose outside the neonatal study period.

16 LIMITATIONS OF THE STUDY

The key limitation of this study is the tertiary status of the Lagos University Teaching

Hospital where routine circumcision is seldom performed. The bulk of circumcision cases seen in LUTH are referred as a result of post-circumcision complications. Consequently, the total number of cases recruited for this study was small. The time available for this period was only a year and this, along with financial constraints on a lone investigator, limited the number of cases that could be recruited for the work. Not all mothers accepted the Plastibell as a method of circumcision. And not all the parents proved to be reliable in assessing certain post-operative parameters such as pain. Although all parents had said initially that they understood how to score pain using the FLACC score, several were unable to do this thus making it impossible to reliably study this parameter. Despite these limitations however, it was expected that the findings should be useful enough to inform circumcision practitioners and provoke further studies into the subject.

17 CHAPTER TWO

LITERATURE REVIEW

Circumcision has been performed as a surgical procedure since antiquity for cultural and religious reasons by many tribes all over the world1. Although the origin is unclear, archeological evidence confirms its practice among some ancient cultures such as the

Babylonians and West African Negroes, perhaps as early as 5000BC2,3. Judaism traces the origin of circumcision to Abraham4,5,6. It is however believed to have started more formally in ancient Egypt where it was possibly used to identify male slaves in the royal palace.

Circumcision is depicted in bas relief, a pattern of writing similar to Hieroglyphics, on a tomb of ancient Egypt and Christopher Columbus was reported to have found circumcised natives on his arrival to the New World more than 500 years ago3,6. This procedure remains the most frequently performed surgical operation in males worldwide and is widespread in the Middle

East, North America and Africa7,8. It is estimated that 1.3 million circumcisions were performed in the US in 1997 and that the circumcision rate in that country is estimated at about 90 percent. In East Africa, especially among the Maasai, circumcision rites have long been a part of community life as a rite of passage9. In Papua New Guinea, the removed foreskin is offered as a mark of respect to certain deities10. Some native American Indian communities also have similar practices7. Circumcision is entrenched among Moslem Arabs and is widespread among Arab immigrants in Europe3,10,11. However, routine circumcision is not universally practiced in Europe. In South and South-East Asia, circumcision is not popular and most males are not circumcised because of Bhuddism16. In West Africa, circumcision is universally practiced for cultural and religious reasons8,12. One in six males in the world is thought to be circumcised and the circumcision rates vary from 65 percent in the

18 US to 98 percent in West Africa. It is as low as 7 percent in Asia and nearly 100 percent in the Middle East9,13,14,15,16

The Circumcision Controversy

There has been a raging argument on the desirability of a mutilating surgery such as circumcision on an unconsenting newborn, especially in view of its very few medical indications13,14,15. Furthermore, it is sometimes opined that circumcision excises the most erogenous part of the male anatomy, leaving the circumcised with diminished penile sexual excitability. Surgical indications of circumcision such as phimosis, paraphimosis and recurrent balanophosthitis, constitute only 1 percent of all circumcisions. Proponents of circumcision cite a low incidence of penile cancer in circumcised males and reduced rates of cervical cancer in wives of circumcised men3,15,16. Critics of this proposition point out that penile cancer rates are equally low among uncircumcised men. Consequently, the low incidence of penile cancer and the strong possibility of a viral aetiology led many authors to conclude that the impact of routine neonatal circumcisions against penile cancer does not justify its widespread practice17. It will take 600 mutilations to protect one child13,17. In

Judeo-Christianity, it is sometimes argued that the religious injunction for circumcision is inviolate and parental decision to circumcise newborn males is unquestioned4,5,6. This argument is also true in African communities where the practice is considered a tribal identity rite of passage. Of recent, circumcision has been ascribed a protective role against heterosexual transmission of HIV/AIDS18,19,20,21. There is strong scientific evidence of diminished transmission among populations which perform routine circumcision, as well as among circumcised homosexual men in the United States20,21,22. Besides, it is known that the membranous part of the prepuce is more susceptible to bruising, microbial penetration and possibly, penetration by the HIV virus21,22. Accordingly, the governments and peoples of

Central and Southern Africa are currently promoting the benefits of circumcision as one of

19 the steps to control the prevalence of HIV19. Whatever the arguments for and against circumcision, the universal practice of this procedure in West Africa makes it a compelling issue to be further studied if its methods are to be improved and its complications reduced.

Circumcision Methods

Although many methods exist for performing this common procedure, none of these is devoid of complications. Whatever method is chosen, the surgeon must be both familiar and adept in its use in order to reduce the possible complication rates3. An ideal circumcision method should have the following properties:

 It should be bloodless.

 The materials used should be disposable and not reusable

 It should be predictably accurate.

 It should not have retained parts.

 It should be safe and not cause untoward injuries.

20 Methods of Circumcision

Although a diverse number of methods of neonatal circumcision exist, the most commonly used are the open dissection, Plastibell, Gomco and the Mogen circumcision methods23,24,25,26.

None of these is free of complications. The methods of circumcision are as various as there have been ideas. The open method had been utilized for millennia until the early 20th century when the desirability for improvements led to the development of a variety of rings and clamps. Prior to the introduction of these devices, the Jews had been using a number of shields in performing religious circumcision rites13,15.Control of bleeding and protection of the glans penis from inadvertent injury were the main driving forces for the development of earlier contraptions. The open method of circumcision evolved into the dorsal slit method, the sleeve method and the guillotine method. These three methods were important efforts made to control bleeding and remained the predominant methods of circumcision until the early twenty-first century24,26.

The Dorsal Slit method

This involves the crushing and division of the two layers of the prepuce at the dorsum of the penis after the prepuce has been freed circumferentially from the glans. The slit is extended to the corona and the prepuce is then divided under direct vision between artery forceps along the corona. The cosmetic result is good and haemostasis is readily achieved either by the application of firm, direct pressure or by the careful placement of ligatures.

21 The Sleeve Method

Here the prepuce is removed in its two component layers. The outer layer is removed first followed by the inner layer. This is done along the corona and haemostasis is then easily secured as has been discussed above. This is thought to be more accurate than the former but is also more painstaking to perform. Besides, the potential bleeders are ligated under direct vision unlike in the former method in which bleeders may not be seen directly.

The Guillotine Method.

In this method, the prepuce is freed circumferentially from the glans and pulled taut. The penis is retracted as far as possible and a bone cutter or a pair of artery forceps is applied just over the glans so that the prepuce can be severed using either a scalpel or a bone cutter. The artery forceps are usually kept in place for seven to ten minutes to ensure that adequate haemostasis has been achieved. This is a quick method of circumcision whose main drawback is that it is a blind procedure at which severe penile injuries like amputation, sometimes occur.

The Mogen Clamp

Shields similar to this have been in use for hundreds of years. This particular clamp was first introduced into the United States in 1955 and has as an added advantage the ability to crush the prepuce and secure haemostasis by using a wing nut to tighten the clamp. It was designed by H. Bronstein24,25,26. This device was essentially a shield but it could also crush tissue. It is the most rapid of all the clamps but it is also the one with which practitioners are least familiar. The major drawback with this device is that although it affords the surgeon the opportunity to have the prepuce in full view at all times during the procedure, which allows for excision of the accurate length of the prepuce desired, the glans is not similarly kept in

22 view and may sometimes be amputated when applied, especially if the jaw-gap allows too

26,27,28. much tissue to be drawn through the opening .

The Gomco Clamp®

Many types of the protective shields have been in use for centuries and these methods bridged the long gap between the era of the open method and that when specific efforts were made to protect the penis from injury. Progress was slow in coming because in western civilizations, doctors were not allowed to advertise their practices nor to own patents25,27.

The first of these devices was the Gomco clamp which was introduced in the United States in

1935, by Yellen25, a distinguished combat doctor in World War 1. He trained as a

Gynaecologist after the war. He did not introduce it until during the Second World War when new recruits were required to be circumcised because of problems with balanitis which plagued their uncircumcised prepuce from desert sand. The name was derived from Goldstein

Manufacturing Company, the initial manufacturer of the clamp, a facility owned by A.A

Goldstein, a friend of Yellen’s. The Gomco is made of four main parts, all metal: a plate, a bell, a yoke and a nut. Under aseptic conditions, the glans is freed from the prepuce and the extent of the prepuce to be excised is marked with a pen. A small dorsal slit is created and it is then possible to place the appropriate size of the bell over the glans. The bell and the prepuce are then passed through the opening in the base of the clamp and fastened to the yoke. The yoke is tightened followed by the excision of the preputial skin distal to the base of the clamp24,25. The Gomco leaves a neat, cosmetically appealing circumcision margin..

Haemorrhage is usually minimal and is effectively controlled since the surgeon is still on hand to deal with any emergency. It is a re-usable device requiring autoclaving while the next patient waits. It is therefore unsuitable for use on a large-scale basis. Besides, the Gomco’s bell is available in only three sizes and so cannot be used outside the neonatal period.

However, it is a very durable instrument. In the past 72 years, it has had only a single design

23 modification involving the addition of a plastic washer that can be autoclaved thus preventing the nut from jamming in the locked position 25. It is today regarded as the most successful and frequently used surgical instrument in the world, and can be used repeatedly following autoclaving. About 39 percent of circumcisions in America are performed using the Gomco clamp and 60 percent with the Plastibell13,27,28. Its durability may however reduce its predictability with repeated usage and autoclaving over time. There is also the likelihood of putting together mismatched parts with the potential for causing significant penile injury27,28.

The Ross Ring

This device was described and used by Ross and others prior to 1956. It was given a U.S. patent in 194229. It is identical to the Plastibell but was made of steel such that the tab or the handle could not be fractured or removed. This is a tourniquet type of circumcision, the first to be described in any U.S. literature, and should prevent any migration because it had a handle which stayed in place. In addition, Ross stated thus. ‘The device is left in place from

24 to 72 hours depending on the age of the patient or until the wound is well closed and capable of maintaining itself in proper relationship without extraneous support28,29. This design by Ross would prevent migration better because it had an angulated handle which stayed in place.

The Plastibell®

The Plastibell was invented a year after the Ross Ring. Although similar to many previous devices, it differed significantly in being made of clear plastic. It was designed to be retained for several days until it fell off 24,29,30. The Plastibell is a plastic shield essentially designed to fit over the glans and so its distal end is open. This shield resembles a cap with a groove at its wider, proximal margin over which a string (accompanying the device) can fit snugly. The distal end of the Plastibell device is elongated into a tab, a handle which is essential for its

24 stability during the procedure and which is only broken off after the ring is secured into place with the suture. That suture is used like a tourniquet and it crushes the skin overlying the glans against the groove in the ring thus shutting off vascular supply to the distal prepucial skin while the ring protects the glans29. This device (fig.1) comes in a sterile pack and is used for up to sixty percent of all childhood circumcisions in the United States24,30. Youth, teen and adult Plastibell devices are also available in Europe. It is a disposable device unlike the

Ross Ring.

Fig 1:The Hollister Plastibell

26 The long period of retention accounts for many of the complications which have become associated with the Plastibell device8,12,31 . Its introduction in 1956 by Donald H. Kariher29 was met with critical acclaim. There is no formal way of measuring what size is appropriate for each individual and so its selection is based on the most likely fit. Its glannular protection ends with the completion of circumcision while the plastic ring is retained for several days solely to secure haemostasis. The bell is inserted into the preputial cavity (over the glans, and under the foreskin) and the foreskin is tied around it with a tight string. Blood flow to the prepuce ceases, and the prepuce distal to the string is excised. After several days, the vestigial preputial skin skirt caught under the string undergoes ischaemic necrosis and falls off, providing a bloodless circumcision margin. It is a plastic version of the Ross Circumcision

Ring. Other disposable plastic devices which have recently come into use are the Tara clamp and the Tibone clamp32. The similar Sunathrone32 is no longer in production. In its present format, the Plastibell ring protects the glans while the margin created by the string helps ensure that the frenulum cannot be cut. There is also virtually no blood loss and, in more skilled hands, it can even be used on haemophiliac boys, a distinct advantage over all other methods31,32. The Plastibell is an ideal tool for use by relatively low-skilled medical and surgical personnel such as midwives, junior doctors and family practitioners since the only real skill required is the ability to tie a surgical knot that will not come undone over a period of about 10 days32. It creates a very neat job with a smooth, bloodless margin. The device is easy to use. It does not have many parts and its disposable presentation allows for many cases to be quickly performed over a short period. This is an advantage in many overcrowded health facilities in sub-Saharan Africa.

Some significant problems have however been encountered with the use of the Plastibell. An undersized device provides a tight fit which soon migrates distally as proximal oedema develops and may cause glannular ischaemia and possible gangrene33,34. An oversized device

27 is likely to migrate in the opposite direction as the attached skin recovers from oedema and shortens thus pulling the device proximally. While incidences of haemorrhage are low compared with the Gomco, this device is more associated with infections35,36. Post- circumcision infections, though rare are seen relatively more commonly with the Plastibell.

This occurs because the ischaemic foreskin becomes progressively more susceptible to bacterial invasion. Most of these are mild and are treated with dressings and antibiotics37,38,39.

Some are catastrophic with cellulitis supervening, as well as necrotizing fasciitis and

Fournier’s gangrene38,40,41. Ischaemia of the glans penis has also been described with penile amputation42. Although some of these complications are not frequently seen in Lagos, some peculiar complications have been documented. These are meningitis, tetanus, acute venous stasis of the anterior abdomimal wall and death8,43. The long fall-off time, proximal migration as well as urethrocutaneous fistula have been reported following its use3,8. The latter is presumably caused by the sustained pressure effect of the plastic ring on the ventral aspect of the phallus where the urethra is subcutaneous. The Plastibell may occlude the urethra if wrongly applied and thus cause an acute urinary retention44. Traumatic bladder rupture and even death have also been reported45. Thus, the Plastibell, though a convenient and widespread circumcision device, has its own fair share of problems43,44,45. Williams and

Kapila35 found a 3 percent complication rate in their series and a satisfaction rate of 96 percent. The Gomco and the Mogen clamps are, on the other hand, much more likely to cause penile lacerations or amputation of the glans28.

Complications of Circumcision.

The complications of this very frequently performed procedure are many and have also been widely documented. The complication rate ranges from 1.5 percent to 5 percent in skilled hands and complication rates of 30 percent to 38 percent have been recorded among unskilled personnel31,41,42. These figures highlight an enormous burden for a surgical procedure largely

28 performed on unconsenting babies for religious and cultural reasons43,45. Some of these complications are life-threatening and others are associated with chronic deformities. The documented complications are many.

Urethrocutaneous fistula.

This is the most common complication of circumcision referred to our centre. Most frequently, it is seen complicating the open method of circumcision when ligatures are applied at the ventral aspect of the penis to secure the frenular arteries. This problem occurs if such sutures are placed too deeply or in the midline. This complication has also been seen with the use of the Plastibell when proximal migration of an over-sized device occurs with associated ischaemia and necrosis of the ventral portion. More often, proximal migration occurs because the foreskin has been pulled too tightly before the device is applied. As the initial oedema subsides and the residual penile skin contracts, it shortens, thus pulling the attached Plastibell ring with it proximally. A fistula may result, or, gross oedema of the phallus distal to the Plastibell may lead to glandular ischaemia and necrosis 39, 41,42,43.

Haemorrhage

Although this complication occurs frequently, it is usually associated more with the open methods of circumcision than with the Plastibell. Most incidents occur from reactionary haemorrhage and can be stopped either by direct pressure alone or with the application of ligatures. The reported incidence varies from 0.1 percent to 35 percent43. An Adrenaline pack is sometimes employed although this is not a widely acclaimed means of arresting haemorrhage in neonates because of some deleterious systemic effects its usage might cause31,43. Sometimes the bleeding is severe enough to require blood transfusion or even cause death if intervention is delayed. Catastrophes such as this commonly occur when a

29 ligature may have slipped or when shoddy history-taking has failed to elicit a family history of a bleeding diathesis 29, 31, 35, 36,37,44.

Amputation

Penile amputation is a common complication of the open method of circumcision especially in the hands of unqualified medical personnel12,26,27,45. Most frequently involved is the glans and occasionally, the penile shaft. Most of these will heal with minimum surgical intervention. Sometimes though, laborious and expensive penile reconstruction will have to be carried out in order to restore function and cosmesis. This complication is most commonly seen with the guillotine method. Although the glans is usually involved, the penile shaft may occasionally be similarly injured. Sometimes, healing is followed by a buried penis with dense cicatrisation around the urethral meatus. Sometimes, the damage is so severe that the external meatus is not even visualized, and an emergency antegrade transvesical catheterization may be needed to maintain normal function and prevent further damage 27,28..

Wound Infection

Post-circumcision wound infection is well documented in the literature. It ranges from superficial infection and cellulitis to septicaemia. Meningitis and tetanus have both been described. Fournier’s gangrene and necrotising fasciitis have been reported as well38,46,47,48 .

The lesion may extend from the hypogastrium to the mid thighs. Antibiotic therapy must be instituted early and serial debridement carried out until wound cover is obtained by skin grafting. Proper management of this calamitous complication requires a multidisciplinary approach involving the paediatric surgeon, the plastic surgeon, the surgical nurses, the nutritionist and the microbiologist 34,38,39.

30 Skin Bridges

This important complication is usually not noticed by parents. It occurs when the coronal edge of the glans becomes adherent to the stump of the circumcised foreskin during healing.

An inclusion dermoid cyst forms which can then have a punctum on either side of the lesion8.

It leaves an unacceptable cosmetic result and may sometimes become infected.

Redundant Skin

This complication results from any of the common methods of circumcision usually when too little of the prepuce is removed. The cosmetic result is usually unacceptable and so some patients will require a re-circumcision if it becomes phimotic25.

Phimosis.

As redundant skin can result from circumcision, so can phimosis, especially when the inner layer of the prepuce has been incompletely excised. It heals with dense adherence to the glans and may cause an obstructive uropathy8,12,25.

Others

The Plastibell and the Gomco are unique in their ability to protect the penis from injury during circumcision24,25. Other methods are, however, not as certain to protect the glans as those two devices. The open method is particularly more likely to cause injuries such as bivalving of the glans penis or other injury to the penile shaft, or worse still, cause an amputation8.

Keloids

Rarely, this immensely disfiguring complication occurs after circumcision. This has been more often described among dark-skinned races and also in North Africa.

31 Safe Circumcision

Two overriding criteria are critical to any successful circumcision method. First, a safe method of circumcision should protect the penis from any injury. The Plastibell meets this important criterion during the procedure48,49,50,51. The second function is haemostasis which is substantially controlled within a short period of applying a strangulating ligature. It is therefore difficult to rationalize the retention of a foreign body on the circumcised penis for ten to fourteen days after the device has ceased to be useful49. Although there is little if any useful data on crushing time for safe hemostasis during neonatal circumcision, all other circumcision devices are removed after achieving a hemostatic crush within minutes while only the Plastibell is retained for 5-14 days. If other methods that do not retain any parts of the circumcision device are attended by no worse haemorrhagic complications, then leaving the Plastibell ring in place for as long as is currently practiced cannot be an advantage and deserves to be re-examined as it may in fact constitute an unnecessary burden for the circumcised newborn males and their parents. At the Lagos University Teaching Hospital, one of the several government funded tertiary institutions in Lagos, the Plastibell is the second commonest cause of circumcision-related injuries in newborn males and most of these complications are due to the prolonged fall-off time of the ring8. Sustained retention or complications ensuing from this are sometimes poorly understood by parents. Penile oedema, necrosis, urinary retention and even death have been documented 45,47. Proximal migration of the ring also occurs and is usually caused either by using an oversized ring or by applying too much traction on the prepuce after separation from the glans52. In the former, the ring fails to make a tight enough fit and may thus migrate under the skin towards the root of the penis. In the latter, as the penile skin retracts after the procedure, it drags the ring proximally. Both of these forms of proximal penile migration can cause degloving penile injuries when the ring has been retained for long enough. The range of serious penile injuries seen in our centre has

32 53 been exhaustively elucidated by Bode et al . Occasionally, a mild inflammatory process ensues which is no more than a cellulitis35,36,37. This is usually amenable to antibiotic therapy.

Another common complication seen in our centre, however, is haemorrhage which is often due to an inefficient way of applying the tourniquet and may sometimes be due to an oversized Plastibell. This is effectively controlled using firm digital pressure upon the removal of the ring or by applying ligatures. This study has, therefore, compared the effects of an early removal of the Plastibell ring in a group of neonatal male circumcisions with another group where the ring is allowed to fall off by itself.

33 AIM

The aim of this study was to investigate possible benefits of early removal of the Plastibell ring when compared with delayed fall-off time of the device in neonatal males presenting for circumcision in Lagos.

OBJECTIVES

1) To compare the rate of post-circumcision haemorrhage in circumcised newborn males

whose Plastibell rings were removed at 24 hours (Subjects) with those in whom the rings

were allowed to fall off without intervention (Controls).

2) To compare the rate of wound infection between the Subject and Control groups of male

newborns circumcised with the Plastibell device.

3) To compare discomfort from circumcision between the Subject and Control groups of

male newborns circumcised with the Plastibell device.

4) To compare the duration of complete wound healing between both groups.

5) To determine the average fall-off time of Plastibell in the control group.

34 CHAPTER THREE

METHODOLOGY

A series of sixty consecutive newborn males were recruited from consenting parents at the

Lagos University Teaching Hospital, LUTH. Institutional Ethical Committee approval was obtained from LUTH authorities (Appendix 1). The patients were divided into two groups consisting of 30 Subjects (S Group) and 30 Controls (C Group). All the 60 newborn males underwent circumcision using the Plastibell device. In the Controls, the Plastibell ring was allowed to fall off by itself as recommended by the manufacturers while in the subjects (S) group, the device was removed on follow-up at 24 hours by the investigator. The circumcision procedure was offered to all patients free of charge but the parents procured the post operative analgesics from the Hospital Pharmacy Department at their own cost.

Pain in the post-circumcision period was assessed using the Face, Leg, Activity, Cry,

54 Consolability test ( FLACC) . This uses 5 different parameters to determine the level of pain experienced by a child recovering from anaesthesia. Each parameter is graded from 0 to 2 so that the minimum score is 0 and the maximum is 10. The scale is reproduced below ( Table

1).

35 THE FLACC SCALE:

Parameter 00 111 222

Face No particular expression or smile. Occasional grimace or frown, Frequent to constant quiv-

withdrawn, disinterested. ering chin, clenched jaw.

Legs Normal position or relaxed. Uneasy, restless, tense. Kicking or legs drawn up.

Activity Lying quietly, normal position, Squirming, shifting back and Arched, rigid or jerking.

moves easily. forth, tense.

Cry No cry ( awake or asleep ) Moans or whimpers, occasio- Crying steadily, screams

nal complaint or sobs, frequent complai-

nts

Consolability. Content, relaxed. Reassured by occasional tou- Difficult to console or

ching, hugging or being talked comfort.

to, distractible.

Table 1

This scale assesses the level of post operative pain in young children recovering from anaesthesia. It is easy enough for parents to understand and to score.

36 Sample Size:

The sample size was determined by a sample size formula for determining 2 independent means36:

n= 1 X 2X(Zα+Zß)X(1-P) 2 1-f (P0 – P1) Where n = Sample size expected.

f = Attrition rate fixed at 10% = 0.1

zα = The possibility of making a type 1 error = 0.5 (5%) = 1.96

zß = The standard normal deviate corresponds to the probability of ß ( i.e .

the probability of making a type 11 error = 20% i. e. power = 80%) 0.84.

Po = Prevalence rate in the control group.

P1 = Known prevalence rate.

P = Mean of Po and P1.

36 A previous study in the United Kingdom , used because no local or national figures are available, reported a Sample Size Index ( SSI) rate of 70% in the study group i.e. P1= 70 %

( 0.71). Expected prevalence in the control group ( Po) = 100% (1.0)

Therefore; n = 1 x 2x(1.90+ 0.84)2 x 0.85 x 0.15 1-0.1 (0.3)2

1.11 x 15.68 x 0.1275 0.09

= 1.11 x 22.21

= 24.65 ≈ 25.

37 Consequently, 25 patients would have been sufficient for this study and another 25 in the control group but a round figure of 30 was selected so that the first 5 could be especially closely monitored.

Patients, Materials and Method

The patients recruited into this study were 60 consecutive healthy male newborns with normal external genitalia whose parents requested for circumcision. Those who met the following inclusion criteria were selected:

Inclusion Criteria

1) Full-term neonates.

2) Circumcision requested by parents.

3) Parents consent to the use of Plastibell.

4) Parents agreement to participate in this study.

5) Patients who live within an hour’s traveling distance of the hospital.

6) Parents of patients who had mobile telephones55,56.

Exclusion Criteria

1) Low-birth weight boys less than 2.5kg.

2) Babies with nappy rash or pemphigus.

3) Those with a family history of bleeding diathesis, or haemophilia.

4) Pre-term babies.

5) Babies with genito-urinary anomalies such as Hypospadias, Epispadias, huge bilateral

hydrocoele or ambiguous genitalia.

6) Buried penis .

7) Ill babies 22,55,56.

38 Grouping

The patients once recruited were randomly selected as Subjects (S) or Controls (C) by closed balloting.

Informed Consent

The parents were fully briefed on the procedure. A written informed consent was obtained from each parent and this was fully explained in local languages to illiterate parents in front of witnesses. Each mother was given a dedicated telephone number through which to call the investigator in case of any complications.

Pre-Operative Protocol

All patients for circumcision had a Packed Cell Volume (PCV) estimation preoperatively.

They were required to arrive in the hospital by 8 a.m on the operation day after having fasted for two hours prior to the procedure. All babies were given intramuscular vitamin K 1 mg stat a day before circumcision to prevent the risk of having to deal with bleeding occurring from haemorrhagic disease of the newborn. This was of importance especially among the Subjects whose Plastibell rings would be removed 48 hours after being given vitamin K.

Surgical Protocol

Each patient was taken into the operating room well covered to prevent hypothermia. He was then restrained in the Lithotomy position by an assistant and the perineum swabbed with

Savlon lotion (1 in 60 concentration). Proper draping was ensured and a penile ring block using 0.25% plain Xylocaine given circumferentially at the root of the penis55,57. All the circumcisions were performed by the investigator under aseptic conditions58. With two pairs of artery forceps, the prepuce was held at 3 o’clock and 9 o’clock positions (Fig.2)

Fig 2: Artery Forceps at 3 o’clock and 9 o’clock positions

40 A third pair of artery forceps was then gently used to free the adherent prepuce from the glans. A 1 cm dorsal slit (Fig.3) was made through a crushed portion and the prepuce was retracted to reveal the smegma in that recess. The smegma was cleaned off with a piece of sterile gauze until a dry bed was seen. An appropriate size of the Plastibell ring was then inserted into the preputial space (Fig 4).

Fig 3: The Dorsal Slit

42 The device was then secured in place by applying a third pair of artery forceps at right angles to the first two pairs holding the prepuce (Fig.4)

It was retained in this position by means of a clamp while a ligature was tightly applied to the skin over the groove in the ring, thus crushing the prepuce against the non-yielding plastic ring.

The skin distal to the ring was trimmed off and the plastic handle broken off to complete the procedure (Fig. 5).

Fig 4: 3rd pair of artery forceps securing the Plastibell in the Preputial Space

Fig 5: The retained Plastibell Ring following excision the Prepuce.

45 Post Operative Care

A petrolatum jelly gauze dressing (Sofratulle) was applied and the patient observed for a minimum of one hour before discharge. Oral Paracetamol, 10-15mg per kg body weight every 6-8 hours and Promethazine 2.5mg every 12 hours were given as analgesia and tranquillizer respectively54,55,57. Parents of the Subjects group were instructed to bring the patients 24 hours post circumcision for removal of the Plastibell ring. All parents were instructed to report sooner if a complication was suspected to have arisen. Written instructions with 24-hour help-line telephone numbers were given to each parent (Appendix

II). The parents of the Control Group were instructed to visit the investigator on alternate days until the plastic ring fell off. Those in the Subject group who had their Plastibell rings removed after 24 hours were taken into a dressing room so their mothers were present. Their genitals were then exposed after removing the Petrolatum dressing and the phallus examined for any sign of bleeding. A sterile dressing pack was opened and a pair of sterile stitch scissors used to remove the string while donning a pair of sterile gloves. In the first 5 cases, the stitch removal was difficult with the traditional stitch scissors. The removal of the string became easier with the use of a small, sharp, stitch scissors, while a pair of artery forceps was used to hold the knot for stability.

Haemorrhage

All babies were observed for one hour, for any bleeding, before being discharged home. All mothers were specifically instructed not to completely cover the babies’ genitals in diapers once at home so that any bleeding occurring would be immediately obvious.

Infection

A second generation cephalosporin such as Ceftazidime, was prescribed for a clinically determined wound infection because of its wide effectiveness against both gram positive and

46 gram negative organisms, its ready availability and the convenient administration which should encourage compliance.

Pain

The persistence of post-operative pain was treated with oral paracetamol and promethazine to keep the babies calm. There were no babies who were averse to taking these oral medications.

Proximal Migration

This particular problem was prevented from occurring by choosing an appropriately-sized

Plastibell and also by not unduly placing traction on the penile skin while applying the string to the plastic ring. The effect was to preserve the length of penile skin that would not be compromised by retracting skin when oedema subsides. Gross penile swelling did not result from circumcision, such that the organ appeared endangered in any form.

The incidence of common complications such as bleeding and infection were recorded on the proforma while the day of complete wound healing was determined with the parents in attendance and also recorded for all babies. Wound infection was categorized based on the classification used by MacLennan58 viz:

Grade 1: Undue hypereamia of the wound.

Grade 2: Serosanguinous exudation from the wound.

Grade 3: Purulent discharge.

Grade 4: Complete wound breakdown.

In this study, the appearance of any of these changes was described as an infection, even though any infection was generally expected to be mild and no more than a cellulitis.

47 Fall-off Day of Plastibell

The fall-off day of the Plastibell ring was determined by the complete separation of the device from the penile shaft such that it fell off by itself. Patients in the Control Group were reviewed every 2 days until this happened. They were requested to visit the clinic on alternate days to monitor their children’s progress until the device fell off. The parents were also instructed to call the investigator if the ring fell off on a day in which they were not scheduled to be at the hospital. They were also advised that any ring which remained in place after 10 days would be surgically removed. This group included even such devices that were partially attached to the penis by the 10th day.

FOLLOW-UP

All patients in the two groups were seen on the first post operative day. Following the removal of the Plastibell ring in the Subject group, patients were seen every other day until the wound was adjudged to be fully healed. Among the Controls, follow-up was conducted every other day also in agreement with the pattern already utilized for the Subjects and recommended by Duncan et al 59 which they found to be satisfactory. Those patients who did not come back to the hospital on specific dates were contacted by telephone and any developments were noted on the proforma as was done for those who showed up. Full wound healing was determined by the presence of any two of three factors enumerated by the investigator and these were noted as follows;

1) Dry muco-cutaneous edge

2) Absence of any discharge

3) Difficult separation of muco-cutaneous junction.

48 DATA ANALYSIS

The Proforma was manually filled with all relevant details for each patient. All data were analyzed on SPSS ® 10th edition spread sheet, a computer software. The results are presented by Graphics such as Tables and Histograms. Means of the 2 groups are compared using student t test.

Association of numerical variables was done by correlation coefficient and references analysis. Unless otherwise stated P value would be < 0.05.

49 CHAPTER FOUR

RESULTS

Age, Weight and PCV

The patients were aged between 7 and 28 days, with a mean age of 11.3 ± 5.3 days. The modal age was 8 days, with 28 (46.7%) babies presenting for circumcision on that day. The patients’ weights ranged between 2.7 and 4.2 kg with a mean weight of 3.4 ± 0.4 kg. The mean Packed Cell Volume (PCV) of the 60 babies was 38.4 ± 5.1 %, with a range of 30.0-

52.0%. The age, weight and PCV of the Subjects and Controls were comparable and no significant difference was observed between the two groups in any of the three variables when subjected to Student’s t-test (Table II).

Table II PRE-OPERATIVE DATA ON STUDY GROUP

Variable Subjects Controls p-value

Mean Age (days) 11.8±5.9 10.9±5.0 0.515

Mean Weight (kg) 3.3±0.4 3.4±0.3 0.316

Mean PCV (%) 39.7±4.3 40.1±4.4 0.421

51 Post-Circumcision Haemorrhage

Overall, four (6.6%) of the 60 neonatal circumcisions in this study were complicated by haemorrhage. There was minor bleeding in 3 ( 10%) of the 30 Subjects and 1 ( 3.3%) of the

30 Controls. One patient each from the Subject and Control Groups bled following slippage of the ligature a few hours after Plastibell circumcision. The other two patients in the Subject

Group bled following removal of the Plastibell ring at 24 hours. All the bleeding episodes were effectively controlled within 5 minutes by firm digital pressure only administered through a piece of dry, sterile gauze. All four cases that bled occurred in the initial period of the study and were among the first seven cases. When subjected to Chi -square analysis, the difference in bleeding as a complication was not statistically significant between the Subjects and Controls (p=0.3006). In both groups, the rate of haemorrhage was low and acceptable and the rate in Subject Group was comparable to the Control Group.

Rate of Wound Infection

Only one (1.7%) wound was infected out of the 60 babies circumcised overall. This occurred in an 8 day-old baby in the Control group whose Plastibell rings had been left to fall off on their own. This constituted 3.3 % of the 30 babies in the Control group. He was noticed to have developed a suppurative local infection under the plastic ring and was given an oral cephalosporin and the ring removed immediately. He subsequently recovered without any ill- effects. No wound infection was recorded in any of the 59 other patients. The value of 1.7% recorded was too low to allow statistical comparison by Chi-square analysis and returned a p- value of 1.0 using Fisher’s Exact Test. It was concluded that there was no difference in the infection rates between the Subjects and Controls.(Table III)

52 Discomfort From Circumcision

Discomfort from circumcision could not be objectively assessed because parents were unreliable in supplying the required data. The number of days of reported pain between the

Subjects and Controls were therefore not subjected to Student’s t-test analysis (Table III).

This is so because the data were incomplete.

Table III: Haemorrhage, Wound Infection and Post- Operative Pain between Subjects and Controls

Variable Subjects Controls p-value

Haemorrhage (%) 3 (10%) 1 (3.3%) 0.3006

Wound Infection (%) 0 1 (3.3%) 1

Post-Operative Pain 0 0 0

54 Fall-off Time of Plastibell Ring in the Control Group

The length of time it took for the Plastibell ring to fall off in the 30 babies in the Control group ranged from 1-7 days with a mean of 4.6 ± 1.6 days. The modal day was Day 6 when

11 ( 36.7%) of the Plastibell rings fell off ( Fig.6) When compared with the one day after which the Plastibell ring was removed in the Subjects, the fall-off day was statistically significantly prolonged among the Controls (p<0.005) Furthermore, there was a significant correlation between Fall-off time of the Plastibell ring and the day of Full Healing within the study group, with early removal leading to faster healing (Pearson’s correlation 0.908, p- value <0.05).

Duration of Complete Wound Healing

Full wound healing in the study group occurred between 5-15 days, with a mean duration of

7.8±2.1 days. The mode was day 6, with 15 (23.4%) wounds assessed as fully healed. The mean duration for full wound healing in the Subjects was 6.2±0.8 days while the mean day of full healing in the Control group was 9.4±1.7 days (Fig.7). Thus, the circumcision wounds in the Control group took a significantly longer number of days to achieve full healing when subjected to Student’s t-test analysis (p<0.005). Besides, the skirt of skin distal to the crush among the Subjects was observed in subsequent follow-up visits to have maintained their integrity (Fig.8). Ischaemia was not observed also.

35 Fall Off day for Plastibell Ring

30 Fig 7

20 Fig. 6

15 Group 1 - subjects

Number Patients of Group 2- Control 10

0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8

Fall off day

Fig: 6

16 Day of Full Healing

Group 1 - Subjects

Number Patients of 6 Group 2- Controls

0 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12

Day of Full Healing

Fig: 7

Fig 8: Appearance of Plastibell after 24 Hours

Fig 9: Removing the Plastibell at 24 hours.

Fig. 10: Plastibell string removed

Fig 11: Plastibell ring is removed.

Fig 12: The Phallus after removal of the Plastibell

CHAPTER FIVE

DISCUSSION

Circumcision is the most commonly performed surgical procedure in male newborns in

Lagos. Most of them are performed by paramedical staff and some by untrained hands while the rest are performed by medical doctors. Among all groups, the complication rate varies from 0.5 percent among doctors to 30 percent among untrained practitioners25,29,31,35,36. Most of the circumcisions seen with Plastibell-related complications in LUTH were performed by people who had some level of training. Some were doctors, some nurses and some were nursing aides8,53. In this study, the complication rate was low probably because of two major reasons: the investigator is a trained surgeon and secondly, the procedures were carried out in a theatre setting where strict asepsis was maintained. The benefit of this level of pre-operative planning became evident when the various data were being analyzed. Minor haemorrhage occurred in 10 percent of the Subject group, and in 3.3 percent of the Control group35. One patient had a wound infection necessitating the earlier removal of the Plastibell after 8 days with a speedy resolution of the symptoms following the use of an antibiotic. None called the investigator as a result of an emergency occurring from carrying out the procedure.

HAEMORRHAGE

This was thought to be the most potentially challenging complication of this study. However, when it did occur in the three cases cited, it was mild and was easily controlled and stopped by using firm digital pressure applied over a piece of dry gauze. In an average time of five minutes, haemorrhage was effectively controlled. It was a low occurrence, acceptable and comparable to the Control. Since haemorrhage was not significant, it follows that early

63 removal of the device is justified (Fig.9 and Fig.10). No further procedures were required

(Fig.11). The Gomco, a device still in use till date, is removed after five to ten minutes, with

49 acceptable rates of insignificant bleeding . It proved the confidence demonstrated more than half a century earlier by an investigator who believed that a circumcision device which had a tourniquet ability would be safe29,59. It would effectively control haemorrhage and also promote quicker wound healing because the burden of wearing a foreign body was removed early and that led to speedy resolution of surrounding tissue reaction.

PAIN

Analgesia was achieved preoperatively by instituting a penile block using 0.25percent plain

Xylocaine. Post circumcision, the combination of oral Paracetamol and Phenergan was probably effective in controlling pain. A literature search revealed other active means of achieving anaesthesia and analgesia among male neonates undergoing circumcision with the

Plastibell to include a ring block at the root of the penis using Bupivacaine and the Eutetic

Mixture of Local Anaesthetic (EMLA) patch60. Most investigators used various combinations of the above medications to achieve essentially the same results. Oedema subsided earlier in the subject group than among the control group. This occurred soon after the Plastibell ring was removed at twenty-four hours.

The surgical community seems to have forgotten the injunction of Ross who designed the precursor of the Plastibell six decades ago when he advised that the ring he designed could be removed in twenty-four hours24,29. It is the adherence to that recommendation in this study which has seen such uniformly encouraging results and therefore justifies the early removal of the Plastibell ring (Fig.12).

WOUND HEALING.

Some differences occurred in the rates of complete wound healing between both groups.

Wound healing in the Subject group was about 3 days faster than in the Control group. This is an obvious consequence of the retention of the Plastibell ring among the Subjects. Healing was not a problem in either group. It occurred earlier in the Subject group and therefore, this is an addition to several other advantages already seen in this study. It is one more reason why the early removal of the Plastibell ring in a neonate who undergoes Plastibell circumcision should be considered safe. The Plastibell is associated with considerable penile oedema which probably contributes to the discomfort experienced by circumcised babies. Its removal allows a rapid resolution of this oedema which is yet another compelling reason why this device should be removed after 24 hours when its haemostatic utility is assured.

The other observation of note is that the duration between the removal of the Plastibell ring among the Subject group and full wound healing as well as the period between the fall-off of the Plastibell among the Controls and the complete wound healing among that group is about the same. The significance of this observation may become clearer when a larger scale study is able to throw more light on this in the future, but this view is supported by the assertion of

Al-Samarrai et al36 that healing does not commence until the ring falls off. Whatever reasons will be found responsible for this, the fact remains that the margin of earlier wound healing seen in the Subject group should be enough of a disincentive to want to retain the Plastibell ring until it falls off by itself.

FALL-OFF TIME

65 The average fall-off time of the Plastibell ring in the Control Group is 7.4 ± 1.7 days. This compares favorably with a similar study conducted in Pakistan by Abdul-Samad et al61who recorded a mean fall-off time of 8.7days. In that same series, an over-all complication rate of

7.4 percent was recorded, but not all the patients were neonates.

OTHER OBSERVATIONS

Such complications of Plastibell circumcision as retention of the ring, oedema of the phallus, urethrocutaneous fistula, migration of the ring and significant wound infection were not seen in this study, in either group. Surrounding tissue oedema also resolved within 24 hours of removing the device in the Subject Group, but among the Control Group, oedema persisted until the Plastibell fell off in a mean period of 7.4 ± 1.7 days. Consequently the cut raw edge of the prepuce just distal to the Plastibell became dry much earlier in the Subject Group and so facilitated earlier wound healing. The key limitations of this study are that it was performed by a trained surgeon among a relatively small number of male neonates in an ideal setting. It may therefore be difficult to extrapolate the findings documented here to the general population among whom non-surgeons and other health-care sector workers perform the bulk of circumcisions. Consequently, further study is required in this area before more impressive conclusions can be drawn. Perhaps the other groups of operators should be properly trained to perform this procedure safely.

CONCLUSION

1. Post circumcision haemorrhage was not significantly different between circumcised

babies whose Plastibell rings were removed at 24 hours and those in whom it was left

to fall off on its own several days later.

2. Wound infection rate was 0% for the Subjects and 3.3% for Controls and there was

no significant infection associated with either of the two groups.

3. Day of Full Healing was significantly shorter among the Subject Group than among

the Control Group.

4. The mean fall-off date for the Plastibell ring among the Control Group was 7.4±1.7

days. The modal day was Day 6 when 11 (36.7%) of the Plastibell rings fell off.

5. It is considered that the early removal of the Plastibell ring in circumcised male

neonates is safe.

RECOMMENDATIONS

1. In light of the significant problems identified with using the Plastibell, it is important

to either modify the device or to modify the way the device is used as demonstrated in

this study.

2. A larger scale study designed as above should be carried out to enable more valid

conclusions to be reached.

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2. Harding Rains AJ, David Ritchie H. Circumcision. In ELBS Edition. Bailey and Love’s Short Practice of Surgery.; 19th Edition. London, United Kingdom. H.K. Lewis & Co. 1984; 57: 1245-1246.

3. Raynor Steven, C. Circumcision. Paediatric Surgery by Keith Ashcraft. 3rd Edition Philadelphia W. B. Saunders’ Company. 1999; 783-786.

4. ‘Abraham’. Microsoft ( R) Encarta ( R ) 2007. DVD. Microsoft Corporation 2006

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61. Abdul Samad, Tariq Wahab Khanzada, Basant Kumar. Plastibell circumcision: A minor surgical procedure of major importance. J Paed Urol 2009 Jun; 6(1): 28-31. PROFORMA

Name of patient. Age.

Religion.

Ethnic group. Address:

Packed Cell Volume.

Group: Subject Control

Date of circumcision ------

Date of removal/Fall-off of Plastibell ring------

Complications:

1) Haemorrhage Yes No

1) Infection Yes No

2) Retained device Yes No

3) Post circumcision intervention Yes No

4) Others

Intervention:

Antibiotic therapy Haemostasis Removal of device Re-circumcision. Other.

Level of patients’ discomfort (assessed by parents):

1) Excessive crying Day 1 Day2 Day 3 Day 4 Day 5 Day 6 Day 7 etc

2) Irritable

3) Poor sleep pattern

4) Normal.

74 5) Day of full wound healing.

APPENDIX 1

APPENDIX II

INSTRUCTIONS TO ALL PARENTS

1. Do not completely cover your baby with pampers in the first day after circumcision.

2. If your baby begins to bleed from the penis, please give me a call and return to the

hospital quickly.

3. If you are not able to get to the hospital at the 9.00am time we agreed is convenient,

please call the cell phone number below and tell me why. I will then call you back to

ask certain questions

4. My cell phone No is 08023131760 and I can be reached day or night

5. Report any other unusual development by phone and /or in person.

6. Your baby should be brought to the hospital on alternate days whether or not his

device is removed until otherwise stated.