“A Study Of Surgical Management Of Intestinal Obstruction”

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

SYNOPSIS OF DISSERTATION

“A COMPARATIVE STUDY ON THE OUTCOME OF STAPLER ANASTOMOSIS AND HAND SEWN ANASTOMOSIS IN ELECTIVE GASTRO INTESTINAL SURGERIES’’

Submitted by Dr. NAGANANDA. L MBBS POST GRADUATE STUDENT IN GENERAL SURGERY (M.S.)

Under the guidance of Dr. ABINASH HAZARIKA M.B.B.S, M.S, ASSOCIATE PROFESSOR DEPARTMENT OF GENERAL SURGERY S.A.H. & R.C., B.G.NAGARA

DEPARTMENT OF GENERAL SURGERY ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA-571448

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE AND Dr. NAGANANDA. L ADDRESS NO. 97, KALPATARU BHAVAN, A.I.M.S., B.G.NAGARA, NAGAMANGALA TALUK, MANDYA DISTRICT, KARNATAKA - 571448. SRI ADICHUNCHANAGIRI INSTITUTE OF 2. NAME OF THE INSTITUTION MEDICAL SCIENCES, B.G.NAGARA 3. COURSE OF THE STUDY & SUBJECT M.S. IN GENERAL SURGERY

4. DATE OF ADMISSION TO COURSE 31st JULY 2013 “A COMPARATIVE STUDY ON THE 5. OUTCOME OF STAPLER TITLE OF THE TOPIC ANASTOMOSIS AND HAND SEWN ANASTOMOSIS IN ELECTIVE GASTRO INTESTINAL SURGERIES’’ BRIEF RESUME OF INTENDED WORK APPENDIX – I 6. 6.1 NEED FOR THE STUDY APPENDIX – IA 6.2 REVIEW OF THE LITERATURE APPENDIX – IB 6.3 OBJECTIVES OF THE STUDY APPENDIX – IC MATERIALS AND METHODS APPENDIX – II 7. 7.1 SOURCE OF DATA APPENDIX – IIA

7.2 METHOD OF COLLECTION OF DATA-INCLUDING SAMPLING APPENDIX – IIB PROCEDURE IF ANY

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS APPENDIX – IIC TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS; IF SO PLEASE DESCRIBE BRIEFLY

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION APPENDIX – IID FOR THE ABOVE

8. LIST OF REFERENCES APPENDIX – III

9. SIGNATURE OF THE CANDIDATE

Gastro-intestinal anastomosis is an integral part 10. REMARKS OF THE GUIDE of GI surgeries. Comparing the traditional hand-sewn method and the most advanced stapling system, helps us understand the pros and cons of each method and the better method of the two.

11. NAME AND DESIGNATION OF {IN BLOCK LETTERS}

11.1 NAME & DESIGNATION OF GUIDE Dr. ABINASH HAZARIKA MBBS, MS ASSOCIATE PROFESSOR DEPARTMENT OF GENERAL SURGERY, A.I.M.S, B.G.NAGARA

11.2 SIGNATURE OF GUIDE

11.3 CO-GUIDE (IF ANY) NO

11.4 SIGNATURE OF CO-GUIDE NO

11.5 HEAD OF DEPARTMENT Dr. R. SRINATH M.B.B.S., M.S., PROFESSOR AND HEAD DEPARTMENT OF GENERAL SURGERY, A.I.M.S, B.G.NAGARA.

11.6 SIGNATURE

12 12.1 REMARKS OF THE CHAIRMAN & The facilities required for the investigation will PRINCIPAL be made available by the college

Dr. SHIVARAMU. M.G., M.B.B.S., M.D. PRINCIPAL, AIMS, B.G. NAGARA.

12.2 SIGNATURE

APPENDIX - I

6. BRIEF RESUME OF INTENDED WORK

APPENDIX - IA

6.1 NEED FOR THE STUDY:

 Conventional (hand-sewn) technique of intestinal anastomosis has been in vogue for

several decades. Staplers which were developed to simplify surgery began to have

significant impact.

 To compare staplers versus conventional anastomosis with respect to certain intra-

operative and post-operative parameters.

 Although stapling is an alternative to hand-suturing in gastro-intestinal surgery, recent

trials specifically designed to evaluate differences between the two in surgery time,

anastomosis time, and return to bowel activity are lacking.

 This trial compares the outcomes of the two in subjects undergoing elective surgery

requiring a single gastric, small, or large bowel anastomosis.

 Restoring intestinal continuity after partial enterectomy and/or colectomy is central to

gastrointestinal surgery. In recent years, mechanical stapling devices have improved and

become more versatile so that many surgeons now consider stapling technique as best

alternate method of anastomosis to suture technique, for speed, safety, efficiency and easy

access.

 The purpose of the study is to compare the feasibility, safety and efficacy of the outcome

of stapler and hand-sewn anastomosis in gastro intestinal surgeries.

APPENDIX - IIB

6.2 REVIEW OF LITERATURE

 Prior to nineteenth century, intestinal surgeries were limited to exteriorization by means

of a stoma or closure of simple lacerations.1

 Lembert then described his seromuscular suture technique in 1826, while Senn advocated

a two layer technique for closure.1

 Kocher’s method utilised a two-layer anastomosis, first a continuous all-layer suture

using catgut, then an inverting continuous seromuscular layer suture using silk. 1

 Anastomosis may be created between two segments of a bowel in a multitude of ways. It

may be end-to-end, side-to-side, or side-to-end.2

 The submucosal layer of the intestine provides the strength of the bowel wall and must be

incorporated in the anastomosis to assume healing.2

 Numerous surgical conditions require the resection of bowel segments and the creation of

reliable anastomoses. As such, anastomotic techniques have been central to the

development of modern surgical practice.

 Traditionally, a wide variety of suture materials have been used to create hand-sewn

anastomoses.

 Although surgical stapling devices have existed since the early 20th century, their use in

routine gastrointestinal surgery has not been widespread until approximately 30 years ago

when their design became much more efﬁcient and convenient. Today, stapled

anastomoses are an integral part of most major abdominal operations.

 Undoubtedly, two of the most signiﬁcant complications related to intestinal anastomosis

remain dehiscence and leakage.

 Indeed, breakdown of an anastomosis is associated with considerable perioperative

morbidity and mortality.

 That being said, the odds of creating a safe and reliable anastomosis can be greatly

increased if certain surgical tenets are respected. These include meticulous technique,

avoidance of tension at the anastomosis, maintenance of good tissue vascularity,

perioperative nutritional optimization, avoidance of concomitant systemic illnesses,

perioperative optimization of medical comorbidities, and avoidance of certain drugs such

as steroids and vasopressors.

 Intestinal anastomoses can nevertheless leak despite optimal conditions, hence the need

for dependable and consistent methods.

 In this context, the current review focuses on operative techniques for stapled small bowel

anastomoses. This is undoubtedly one of the most frequently encountered areas of

elective general abdominal surgery.

 Excellent technique in stapled anastomoses of the small bowel is of paramount

importance to both practicing surgeons and trainees.

 Restoring intestinal continuity after partial enterectomy and/or colectomy is central to

gastrointestinal surgery.

 Lembert described his interrupted seromoscular suture technique in 1826 which became

the mainstay in gastrointestinal surgery in the second half of the century.

 Next a Connell stitch is made in both ends. The Connell stitch is made by passing the

suture from the outside in, then inside out, on one end. The same step is repeated on the

other end in the form of a continuous U-shape.

 Currently, the single-layer extramucosal anastomosis is popular, as advocated by

Matheson of Aberdeen, as it probably causes the least tissue necrosing or luminal

narrowing.

 However, in all cases catgut and silk are being replaced by synthetic polymers.

 The introduction and widespread application of stapling devices helped revolutionize the

technical aspects of surgery that have allowed minimally invasive procedures to be

developed.

 Thus, in recent years, mechanical stapling devices have improved and become more

versatile so that many surgeons now consider the stapling technique as best alternate

method of anastomosis to the suture technique, for speed, safety, efficiency and easy

access.

 A number of benefits conferred by the use of stapling instruments such as minimizing

tissue manipulation and trauma, less bleeding and edema at the anastomosis, a quicker

return of gastrointestinal function and a more rapid patient recovery, have been claimed

by the manufactures.

 Conversely, stapling techniques have been criticized on the grounds of expense, that no

improvement in anastomotic security has been observed and that there is the possibility of

stricture formation.

 During the first 3 to 5 days, termed the inflammatory phase of wound healing, the

collagen matrix undergoes degradation by metalloproteinases.2

 It is in this initial phase that the integrity of the anastomosis depends almost entirely on

technical factors, suture materials, or the integrity of stapled margins of bowel.2

 Around the fifth postoperative day there is a crucial switch from collagen degradation to

collagen deposition, which corresponds to the transition from the inflammatory phase to

the fibroplasia phase.

 The fibroplasia phase reaches its maximal level at day 7.

 Any delay or impairment of the fibroplasia phase can result in the potentially catastrophic

consequence of anastomotic dehiscence.

 Indeed, it is at the end of the first postoperative week that anastomotic dehiscence usually

occurs and becomes clinically evident.

 Although it may seem that surgical stapling devices have completely supplanted hand

suturing of bowel anastomoses, hand suturing remains a crucial skill in every surgeon's

armamentarium.

 Hand suturing uniformly invokes an inflammatory response from dragging the suture

material through the bowel.

 The choice of suture material used by surgeons is not based on a strong preponderance of

scientific evidence.

 Everting and inverting anastomoses have come in and out of favor over the last 2

centuries, as have many anastomotic techniques.

 Recommendations for best practices in creating a GI anastomosis :

1. Ensure an adequate blood supply, eliminate tension, maintain hemostasis, and handle

tissues gently. Expert opinion without explicit critical appraisal, or based on

physiology, bench research or “first principles.”3

2. Use an inverting (serosa-to-serosa), or an everting, with minimal exposed mucosa,

technique.

3. Close mesenteric defects to avoid internal hernia.

4. Consider a stapled technique for ileocolic anastomoses; elsewhere in the GI tract

either a hand-sutured or stapled anastomosis may be employed. 3

5. A single-layer anastomosis is an acceptable technique.

 Many published studies have compared inverting and everting anastomoses through out

the GI tract.

 It is clear that with everting anastomoses, the role of the omentum and other peritoneal

defense mechanisms is increased because of the need to seal the anastomosis and assist in

healing.

 Although everting patterns do not initially impinge on intestinal lumen, stenosis of the

anastomosis may result from extraluminal adhesions and increased fibroplasia.

 Currently, inverted anastomosis is the most widely used technique worldwide.

 In this study, we compare hand suturing with surgical stapling in patients undergoing

elective gastric surgery.

 Surgical stapling were first introduced by Hultl, Humer in 1908.4

 The modern era of mechanical staplers was launched when American surgeon Mark

Ravitch observed a Russian surgeon in Keiv operating with a stapler on the lung.4

 The basic instruments are the LDSTM (Ligates and divides to save), TA 30TM

(thoracoabdominal), TA 55TM, TA 90TM, GIATM (gastrointestinal anastomosis), and the

EEATM (end-to-end) surgical staplers.5

 The LDS is employed in dividing mesentry, mesocolon, and the omentum. Although

ingenious has been the least successful of the stapling instruments.5

 The GIA, TA 30, TA 55, and the TA 90 are used for opening, closure, resection and

anastomosis.5

 Despite comparable results in terms of mortality, anastomotic leak, and duration of

procedure, the rate of stricture at the anastomotic site is considerably higher with staples

anastomosis than with strictures.

 The source of foreign materials eliciting this reaction was the stapler cartridges.

 Randal Baker’s group has popularized the “science of stapling” to promote awareness on

how gastro-intestinal leaks from staple lines can occur.2

 The cause of leaks fall into two key categories: mechanical/tissue causes that occur

postoperative day 0 to 2 and make up the vast majority of leaks. Ischemic causes that

occur postoperative days 5 to 7, but are very rare.2

 Principles of avoiding mechanical/tissue causes of leaks include the following :

- Optimimal stapling allows adequate time for tissue compression and creep(elongation

when crushing force applied)

- Stress relaxation is reduction in the amount of force required to maintain applied

displacement and is important to avoid tearing of tissues from excess tissue shear or

tensile stress.2

APPENDIX - IC

6.3 AIMS AND OBJECTIVES

To compare hand suturing with surgical stapling in a prospective cohort study in patients undergoing elective gastrointestinal surgeries.

APPENDIX - II

7. MATERIALS AND METHODS

APPENDIX - IIA

7.1 SOURCE OF DATA:

This study is conducted in the Department of General Surgery at Sri

Adichunchanagiri Hospital and Research Centre, B.G.Nagara, Mandya district.

A total of 30 cases which meet the inclusion and exclusion criteria to be included in this hospital based prospective comparative study conducted for a duration of 18 months. The study population includes all patients who undergo elective gastrointestinal surgeries.

Study design: Open-label, prospective, randomized, interventional, parallel, controlled trial to compare surgical and subject outcomes between stapled and hand-sutured groups.

APPENDIX - IIB

7.2 METHOD OF DATA COLLECTION:

 Data will be collected from patients who are admitted in surgical wards of SAH & RC,

requiring gastro intestinal surgeries.

 Clinical study will be through questionnaires and clinical examination.

 All patients will undergo routine and special investigations.

 All 30 patients to be classified accordingly into 2 groups with 15 in each of them. The

first group will be the hand-sewn anastomosis group which include cases with at least one

bowel anastomosis without the use of staplers. The second group is the stapler

anastomosis group which includes cases with at least one bowel anastomosis done with a

stapler. It also includes cases with multiple bowel anastomoses done with both hand

sewing and stapler.

Following parameters to be compared :

1. Duration of surgery.

2. Return of bowel movments.

3. Oral feeding starting day.

4. Hospital stay.

5. Duration of anastomosis.

6. Early postoperative complications, and late postoperative complications.

7. Return to work and mortality.

The following statistical test to be used to compare the results of control group and study group:

 Patients to be randomly allotted to control or study group.

 Independent samples T-Test to compare mean values between methods.

 Chi-Square test to compare proportion of the two value.

The observation will be analysed statistically and concluded.

INCLUSION CRITERIA :

1. All patients admitted to the surgery wards requiring elective gastro-intestinal

surgeries who undergo bowel anastomosis.

2. Male or female subjects (between the ages of 18 and 80 years) undergoing elective

surgery requiring a gastric, small, or large bowel anastomosis.

3. Subjects who give written informed consent after reviewing the informed consent

document, will be eligible for enrollment into the trial.

EXCLUSION CRITERIA

1. Paediatric age group (< 18 years)

2. Gastro-intestinal anastomosis done in emergency setting, Biliary-enteric anastomosis.

3. Patients refusing to join the study or left the hospital before final evaluation.

4. Patients with prior chemo-radiation.

5. Patients unfit for anaesthesia excluded from the study.

6. All pregnant women are excluded from the study.

7. Patient above 80 years of age who are not operated on.

8. Patients of coagulopathy and on anti-coagulant therapy.

APPENDIX - IIC

7.3 Does the study require any investigations or interventions to be conducted on patients or other animals; if so describe briefly:

YES, but the study does not include any animal experiments. The following routine pre- operative investigations will be carried out in both the group of patients after taking written and informed consent. INVESTIGATIONS:

1. Routine investigations

a. Haemoglobin percentage

b. Total count

c. Differential count

d. Erythrocyte sedimentation rate

e. Bleeding time

f. Clotting time

g. Urine for protein, sugar and microscopy

h. Random blood sugar

i. Blood urea

j. Serum creatinine

k. Serum electrolytes

l. HIV/ HbsAG

m. Blood grouping

n. Chest radiograph

o. Electrocardiogram

2. Specific investigations

a. Ultrasound abdomen and pelvis

b. Liver function test

c. PT, aPTT, INR

d. CT Scan

e. Esophagogastrodoudenoscopy

f. Colonoscopy

g. Erect abdomen radiograph

INTERVENTION

1. The subjects will be allocated into two groups according to the type of anastomosis, hand

sewn and stapler. The allocation to the groups will be at random decided by affordability

of stapler by the patient and need for use of stapler. Both hand sewn and stapled

anastomosis will be further divided into three sub-groups according to the site of

anastomosis.

2. All the hand sewn anastomosis will be with either single layer or double layer /

interrupted or continuous technique of anastomosis using 3-0 / 2-0 polyglactin (vicryl).

3. In the double layered technique, 3-0 silk to be used for outer seromuscular layer. A full

standard exploration to be done as per the pathology under necessary anaesthesia decided

by anaesthesiologist.

4. Staplers to be used in Anastomosis are Linear cutting staplers (TLC 55, 75), Linear

anastomosing staplers (TCR 55, 75), Circular anastomosing staplers (CDH 25, 29)

APPENDIX – II D

7.4 PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A “A COMPARATIVE STUDY ON THE OUTCOME OF STAPLER a Title of the study ANASTOMOSIS AND HAND SEWN ANASTOMOSIS IN ELECTIVE GASTRO INTESTINAL SURGERIES’’

Dr. NAGANANDA. L NO. 97, KALPATARU BHAVAN, Principle investigator b A.I.M.S., B.G.NAGARA, (Name and Designation) NAGAMANGALA TALUK, MANDYA DISTRICT, KARNATAKA - 571448.

Dr. ABINASH HAZARIKA Co-investigator MBBS, MS c ASSOCIATE PROFESSOR (Name and Designation) DEPARTMENT OF GENERAL SURGERY, A.I.M.S, B.G.NAGARA Name of the Collaborating DEPARTMENT OF GENERAL SURGERY, d Department/Institutions A.I.M.S., B.G.NAGARA

Whether permission has been obtained from e the heads of the collaborating departments YES & Institution Section – B APPENDIX I Summary of the Project Section – C APPENDIX IC Objectives of the study Section – D APPENDIX IIB Methodology Where the proposed study will be A SAH & RC, B.G.NAGARA undertaken B Duration of the Project 18 MONTHS C Nature of the subjects: Does the study involve adult patients? YES Does the study involve Children? NO Does the study involve normal volunteers? NO Does the study involve Psychiatric patients? NO Does the study involve pregnant women? NO

D If the study involves health volunteers I. Will they be institute students? NO II. Will they be institute employees? NA III. Will they be Paid? NA IV. If they are to be paid, how much per NA session?

E Is the study a part of multi central trial? NO

F If yes, who is the coordinator? (Name and Designation) NA

Has the trial been approved by the ethics NA Committee of the other centers?

If the study involves the use of drugs please NA indicate whether.

I. The drug is marketed in India for the NA indication in which it will be used in the study.

II. The drug is marketed in India but not for the indication in which it will be used in the NA study

III. The drug is only used for experimental use in humans. NA

IV. Clearance of the drugs controller of India NA has been obtained for:

 Use of the drug in healthy volunteers  Use of the drug in-patients for a new indication. NA  Phase one and two clinical trials  Experimental use in-patients and healthy volunteers.

G How do you propose to obtain the drug to be used in the study? - Gift from a drug company NA - Hospital supplies - Patients will be asked to purchase - Other sources (Explain) H Funding (If any) for the project please state - None - Amount NA - Source - To whom payable

Does any agency have a vested interest in the I NO out come of the Project?

Will data relating to subjects /controls be stored J NO in a computer? Will the data analysis be done by K - The researcher? YES - The funding agent NO L Will technical / nursing help be required from the staff of hospital. NO

If yes, will it interfere with their duties? NA

Will you recruit other staff for the duration of NA the study?

If Yes give details of NA I. Designation II. Qualification III. Number IV. Duration of Employment

M Will informed consent be taken? If yes YES

Will it be written informed consent: YES Will it be oral consent? NO Will it be taken from the subject themselves? YES Will it be from the legal guardian? If no, give YES reason:

N Describe design, Methodology and techniques APPENDIX II

Ethical clearance has been accorded.

Chairman, P.G Training Cum-Research Institute, A.I.M.S., B.G.Nagara. Date :

PS : NA – Not Applicable

APPENDIX – III

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Principles of Surgery, Ninth edn; chapter 29, Colon, Rectum, and Anus. 2010; 1028-

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4. Josef E. Fischer, Fischer’s Mastery of Surgery, Sixth edition Volume One 2012, part

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5. Hugh Dudlay, David Cartar and RCG Russel, Rob and Smith’s Operative Surgery

Alimentary Tract and Abdominal Wall (Colon, Rectum and Anus) Fourth edition;

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16. Smith SRG, Connolly JC, Crane PW: The effect of surgical drainage materials on

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