Rajiv Gandhi University of Health Sciences s32

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES 4TH T BLOCK , JAYANAGAR BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the Candidate and Dr.Basawesh V Patil Address Dept. of General Surgery Mahadevappa Rampure Medical College, Gulbarga Karnataka

2 Name of the Mahadevappa Rampure Medical College, institution Gulbarga Karnataka

3 Course of Study and M.S.GENERAL SURGERY Subject

4 Date of admission to June 2010 Course

5 Title of the Topic A STUDY TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT AGAINST PEDICLED OMENTAL GRAFT IN PATIENTS WITH DUODENAL PERFORATIONS

6 Brief resume of intended work 6.1 Need for the Duodenal ulcer perforations are a common cause of peritonitis. The study classic pedicled omental patch that is performed for the 'plugging' of these perforations was first described by Cellan-Jones in 1929. In this, a strand of omentum is drawn over the perforation and held in place by full thickness sutures placed on either side of the perforation, and this procedure has become the "gold standard" for the treatment of such perforations.1 Although it is commonly, and wrongly attributed to Graham, who described the use of a free graft of omentum to repair the perforation in 1937.2 However, occasionally large perforations of the duodenum may be encountered in which there exists the threat of post-

1 | P a g e operative leakage following closure by this simple method. Here, other surgical options such as partial gastrectomy, jejunal serosal patch, jejunal pedicled graft, suturing of the omentum to the nasogastric tube, proximal gastrojejunostomy, or even, gastric disconnection may be deemed necessary for adequate closure.

Commonly, duodenal ulcer perforations are less than 1 cm in greatest diameter, and as such, are amenable to closure by omentopexy. It is generally felt by many surgeons that mobilization of the omentum on its pedicle from the colon, and placement of sutures into the normal duodenum away from the perforation makes the performance of omental patch safe even in the presence of large sized perforations.3 However there is controversial evidence from some of the studies conducted which proved free omental graft superior to pedicled omental graft. 4 Moreover there is evidence from studies which concluded that a Free Omental Plug can be used safely and reliably to treat large duodenal perforations that are more than 25 mm in size. 5

This study is aimed at comparing the efficacy of these two commonly used omental patching techniques in management of duodenal ulcer perforations of size up to 20 mm. Hence this study will answer the following research question. Is Free Omental Graft superior to Pedicled Omental Graft in preventing post-operative leak in duodenal perforations or vice versa?

6.2 Review of Duodenal ulcer is a common disease characterized by the presence of a Literature well-demarcated break in the mucosa that may extend into the muscularis propria of the duodenum. A duodenal ulcer occurs when an alteration occurs in the aggressive and/or protective factors such that the balance is in favour of gastric acid and pepsin. Any process that increases gastric acidity (e.g. individuals with increased maximal and basal acid output), decreases prostaglandin production (e.g. NSAIDS), or interferes with the mucous layer (e.g. H.pylori infection) can cause such an imbalance and lead to peptic ulcer disease.

More than 95% of duodenal ulcers are found in the first part of the duodenum; most are less than 1 cm in diameter. The prevalence of duodenal ulcer is estimated to be 6-15% in the general population. In older patients, admission rates of duodenal ulcer perforation increased and gastric ulcer perforation decreased in the last decade. Duodenal perforation currently accounts for approximately 75% of peptic perforation.

Emergency surgery remains the mainstay of treatment of perforated duodenal ulcers. Factors such as concomitant diseases, shock on admission, delayed surgery (>24 hrs), resectional surgery and postoperative abdominal and wound infections have been associated with increased morbidity and mortality in perforated ulcer patients. For decades, delay in operative treatment has remained a primary

2 | P a g e determinant of morbidity, mortality and cost. The most frequently performed operation for a perforated duodenal ulcer is Omentopexy. 6

The Omentum and its special properties

The greater omentum is nothing but a large fold of peritoneum that hangs down from the greater curvature of the stomach like an apron to a variable extent over the intestinal loops. It appears as a thin fenestrated membrane with varying amount of fat deposition. Apart from serving as a storehouse of fat, it protects the peritoneal cavity from infections by virtue of its "milky spots," which are nothing but collections of macrophages. It is also said to limit the spread of intraperitoneal infections by moving to the concerned site and sealing it from the nearby area, a function that has made the British surgeon Rutherford Morrison to rightly name it as "The policeman of the abdomen" in the early 20th century. In spite of all these valuable functions, the omentum is often forgotten.

In the past, the omentum was considered to be an inert tissue without much biological significance. But since the beginning of the last century, innumerable studies and trials have been conducted by surgeons and scientists all over the world, which have proven that the omentum is a unique, physiologically dynamic tissue with immense therapeutic potential.

It is a highly vascular organ with a rich source of angiogenic factors that promote the growth of blood vessels into whatever tissue it is placed close to. The potent lymphatic system of the omentum can absorb enormous amounts of edema fluids and remove metabolic wastes and toxic substances. Recent studies have revealed that the omentum, apart from being a great source of various growth factors, neurotransmitters, neurotrophic factors and inflammatory mediators, also contains omnipotent stem cells that can differentiate into a variety of cell types. It provides an excellent plastic material against inflammation and irradiation.

Anatomically, the attachments of the omentum and the arrangement of the vascular arcades are in such a way that it can be lengthened to an unbelievable extent at a vascular pedicle, exteriorized or detached using microvascular techniques for various intra-abdominal and extra- abdominal procedures. The arterial and venous supply to the omentum are derived from the branches of the right and left gastroepiploic vessels that course along the greater curvature of the stomach. Division of the right or left gastroepiploic artery and the vasa recta along the greater curvature of the stomach with mobilization of the omentum from the transverse colon allows the development of a vascularized omental pedicle flap (Cellan-Jones graft).7

For perforated duodenal ulcers, two commonly performed procedures are Pedicled omental grafting (Cellan-Jones patch) and Free omental

3 | P a g e grafting (Graham’s patch). The omental plug can be reliably used for occluding large duodenal defects, wherein it promotes healing through a combined process of inflammation, granulation, vascularization and fibrosis, eventually providing a normal duodenal mucosal cover to the perforation site.3

The studies done in the past to determine the superior technique were inconclusive because the study results were highly controversial. While most surgeons prefer to use pedicled omental graft to preserve vascularity, some studies have proved otherwise. According to a study conducted in 2006, the post operative leak rates are as higher as 12% in pedicled omental graft as compared to 0% in free omental graft4 whereas another study conducted by Chaudhary A, Bose SM et al had proved pedicled omental grafting as a superior technique. 8 6.3 Objective of the To compare the efficacy of Free Omental Graft(Graham’s Patch) with study Pedicled Omental Graft(Cellan-Jones Patch) in patients with duodenal ulcer perforations of size up to 20 mm. 7 Materials and methods 7.1 Source of Data Patients undergoing emergency laparotomy who are provisionally diagnosed with perforated duodenal ulcer at Basaveshwar Hospital between 2010 to 2013 Inclusion criteria : All patients diagnosed with perforated duodenal ulcer who are fit to undergo surgery Exclusion Criteria : 1) Very large perforations exceeding 20 mm in size 2) Patients having severe co-morbidities i.e. shock, septicaemia , failure of other organ systems, recent MI, malignancy 3) Patients in whom malignant duodenal ulcer is suspected 4) Patients having multiple perforations 5) Patients who have undergone GI surgeries in the past 7.2 Method of Study Design: Collection of Data (including sampling  Type of Study: Comparative Study procedure, if any)  Period of study: Oct 2008 To September 2010  Period required for data collection: 1yrs  Data analysis and reporting: 6 months.

Sample Size:

By reviewing literature it was found that a study done by Jani et al summarises the rate in pedicled omental graft being 12% compared to 0% in case of free omental graft.4

The following formula was used to calculate the sample size required for this study.

N= [2(Zα+Zβ)2 pq]/ d2

4 | P a g e P=(p1 +p2)/2=(12+0)/2=6 q= 100-p d=12-0=12 Zα=1.65 Zβ=0.84 N=48

Due to limitation of patients presenting in our hospital we assign the sample size by the “Rule of Thumb” by which 30 patients are allotted on each side by simple randomization.

PLAN OF STUDY: The patients suspected of duodenal perforations undergoing emergency laparotomy will be divided into 2 groups of 30 patients each based on the technique of Simple Randomization. Patients will be allotted into Groups A and B as per computer generated random numbers. Group A: Pedicled Omental Graft Group B: Free Omental Graft Results of the study will be analysed using Chi-square test for categorical data and “T” test for continuous data.

METHOD:  The suturing technique including the suture material will essentially be the same in all the cases.  A total of three sutures will be placed onto the normal healthy duodenum on either side of the perforation, a strand of omentum then placed directly onto the perforation, and the sutures will be knotted above this. 2-0 silk will be used for this purpose.  No attempt will be made to close the perforation prior to placing the omentum as a graft.  Special precaution will be taken not to leave any residual fluid in the abdominal cavity after peritoneal wash.  Two intraperitoneal drains will be placed. Malecot`s catheter of size 24 will be used for this purpose.  Postoperatively, both the groups will be monitored in terms of no. of days of drain requirement, total drain quantity, no. of days of post-operative hospital stay, symptoms, morbidity and mortality. Each patient will be followed up until discharge post operatively.  Post operative leakage will be identified by the presence of bile in the drain fluid and its quantity.  Post operatively all patients will be given Proton Pump Inhibitors i.e, Inj. Pantoprazole 40 mg iv twice daily for a minimum of 7 days.

7.3 Does the study require any

5 | P a g e investigations or interventions to be  COMPLETE BLOOD COUNT conducted on  HIV patients or other  HBsAg humans or animals?  S.Creatinine If so, please describe  B.Urea briefly.  XRAY ABDOMEN  USG ABDOMEN

7.4 Has a ethical clearance been obtained from your YES institution in case of 7.3 ?

8 List of references 1) Cellan-Jones CJ. A rapid method of treatment in perforated duodenal ulcer. BMJ. 1929;36:1076–7. 2) Graham RR. The treatment of perforated duodenal ulcers. Surg Gynecol Obstet. 1937;64:235–8. 3) Sanjay Gupta, Robin Kaushik, Rajeev Sharma, Ashok Attri. The Management of Large perforations of duodenal ulcers. BMC surgery 2005, 5:15 4) Jani, Kalpesh, Saxena, Vaghasia, Rasik. Omental Plugging for large-sized duodenal peptic perforations: A Prospective Randomized study of 100 Patients. Southern Medical Journal. 99(5):467-471, May 2006 5) Sharma D, Saxena A, Rahman H, Raina VK, Kapoor JP. 'Free Omental Plug': A Nostalgic Look at an Old and Dependable Technique for Giant Peptic Perforations. Dig Surg. 2000;17:216–8. 6) Timothy J. Broderick, Jeffrey B. Mathews. Ulcer Complications, Maingot’s Abdominal Operations, 11th Edition, Mc Graw Hill , 2007; 12:357. 7) Alagumuthu M, Das BhupatiB, Pattanayak SibaP, Rasananda Mangual. The omentum: A unique organ of exceptional versatility. Indian journal of surgery, 2006; 68:12-13 8) Chaudhary A, Bose SM, Gupta NM, Wig JD, Khanna SK. Giant Perforations of Duodenal Ulcer. Ind J Gastroenterol. 1991;10:14–5. 9) Karanjia ND, Shanahan DJ, Knight MJ. Omental patching of a large perforated duodenal ulcer: a new method. Br J Surg. 1993;80:65.

6 | P a g e 9 Signature of Candidate 10 Remarks of the Guide 11 Name & Designation of (in block letters) 11.1 Guide 11.2 Signature

11.3 Co-guide (if any) 11.4 Signature

11.5 Head of the Dept. Dr. S.A.Halkai Professor and Head of Dept. of Surgery Mahadevappa Rampure Medical College, Gulbarga 11.6 Signature

12 12.1 Remarks of the Chairman & Principal 12.2 Signature

For Study Purposes

Record no:

Study Group: A / B

7 | P a g e PROFORMA

Patient Details Name: Age:

Sex: M / F Registration no:

Date of Admission: Address:

Date of Discharge:

Brief History Chief Complaints:

Other relevant history:

Examination Vitals Pulse rate BP Temp Respiratory Rate General Examination:

8 | P a g e Systemic Examination

Other relevant examination:

Provisional Diagnosis:

Investigations CBC

9 | P a g e USG Abdomen X-Ray Other

Operation Details Name of Surgery: Exploratory Laparotomy Date of Surgery: Anaesthesia: Intra-Op findings: Site of Perforation:

Size(in mm):

Nature of free fluid:

Other findings:

Type of Free Omental Graft / Pedicled Omental Graft Omentopexy:

Drain Chart Post-Op day Quantity (in ml) Nature of Drain Day 1 Day 2 Day 3 Day 4 Day 5

10 | P a g e Further days

Post-Operative Details No. of days of drain requirement Total Drain Quantity (in ml) No. of days of Post-Op hospital stay Persistent symptoms, if any

Other complications, if any

11 | P a g e CONSENT FOR PARTICIPATION IN RESEARCH

Mr./Mrs.______we are requesting you to enroll yourself in study titled “A STUDY TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT AGAINST PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS” conducted by Dr.P.Umashankar , postgraduate student in MS GENERAL SURGERY under the guidance of DR I.V.UPPIN MS at J. N. Medical College, Belgaum.

Objective / purpose of this study:

You have been requested to participate in research because we find your profile matching with our study group.

Your participation in the research is absolutely voluntary. Your decision to participate in the study or otherwise will not affect your relationship with J.N.M.C. If you decide not to participate, you are free to withdraw at any time.

This study is being done to compare two techniques used in management of perforated duodenal ulcers which are widely practised all over the world. Patients who are provisionally diagnosed pre-operatively as perforated duodenal ulcers are recruited for this study to learn about the post operative outcome in terms of post-operative leakage.

Procedure:

Two commonly performed techniques in management of duodenal perforations i.e. Pedicled Omental Graft (Cellan-Jones patch) and Free Omental Graft(Graham’s patch) are compared in this study.

Risk and benefits:

There is no increased risk involved in becoming a part of this study and the complications are those which are normally anticipated. This study will help us to estimate the incidence of post operative leakage in comparison with the two

12 | P a g e techniques involved. The results derived at the end of study will benefit all similar patients admitted in this hospital.

Withdrawing / Removal from the study:

The participant has full freedom to withdraw from the study whenever he/she wishes and without prior notice. . Even if you decline to participate, there will not be any change in the line of your management or the relationship with your doctor. You will be told about all the new information that may affect your decision to participate in the study. The Investigator may also exclude a participant from the study at anytime.

Privacy and Confidentiality:

The only people to know that you are a research subject are the members of research team. No information about you or provided by you during the research will be disclosed to others without your written permission except:

1. In emergency to protect your rights and welfare. 2. If required by law.

Institutional / Sponsors policy:

If any unforeseen complications or injury occurs during the period of study the participant will be given the best available treatment within the limitations of KLE’s Prabhakar Kore Hospital General ward.

Financial incentives for participation:

The participant will neither get any financial incentives during the period of study nor will be asked to pay for the purpose of this study.

Contact details :

In case you have any questions related to the study, please feel free to contact the Principal investigator Dr.P.Umashankar at anytime (Phone no. 9731095741).

13 | P a g e Authorisation to Publish Results:

When the results of the research are published or discussed in a conference, no information will be displayed that would disclose your identity. Any information that is obtained in connection with this study and that can be identified with you will remain confidential

Consent Statement:

I, the undersigned, have been explained in my own vernacular language about the study. I am aware that my participation in this study is voluntary and I could withdraw at any time. Also I had been given enough time to comprehend and clarify my doubts about the study and my rights as a study participant.

Signature or the left thumb impression of the participant or legally authorized representative

Participant’s name______Signature______

Witness’s name ______Signature______

Investigator’s name ______Signature______

Place ______

Date ______

14 | P a g e BUDGET PLAN

Sample size = 30 in each group

 Cost for collection of material and internet =Rs 1800

 Cost for photocopies of proforma/consent forms = Rs 3000

 Cost for preparing and writing Thesis = Rs 8000

 Preparation of Synopsis = Rs 3500

 Informed consent = Rs 1000

 Photographs and copies of dissertation = Rs 3000

 Miscellaneous =Rs 5000

Total Cost =Rs 25,300

15 | P a g e Time plan

PHASE TIME PERIOD OUTLINE OF PLAN

1. Identification of the Problem I June 2008 to 2. Review of Literature October 2008 3. Making of proforma

4. Writing of Synopsis and submission for approval.

II Dec 2008 to Data collection

Dec 2009

Analysis of collected data III Jan 2010 to

June 2010 Discussion

IV Oct 2010 Due date of submission of Dissertation.

16 | P a g e PLAN OF ANALYSIS

Group A Group B (30 patients) (30 patients) Type of Omentopexy Pedicled Omental Graft Free Omental Graft performed Avg. no. of days of drain requirement Avg. quantity of drain (in ml) Avg. no. of days of post- op hospital stay Avg. no. of patients with persistent symptoms Avg. no. of patients with other complications

Results of the study will be analysed using Chi-square test for categorical data and “T” test for continuous data.

17 | P a g e From, Dr. P.Umashankar Post Graduate, Department of General Surgery, J.N.Medical College, Belgaum-590 010. To, The Registrar (Evaluation) KLE Academy of Higher Education & Research, Belgaum-590010, Karnataka. (Through Proper Channel) Sub : Submission of Synopsis of Dissertation. Respected Sir, Herewith, I am submitting synopsis of dissertation work “A STUDY TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT AGAINST PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS” for registration in M.S. (General surgery) of KLE Academy of Higher Education and Research (Deemed University), Belgaum. Kindly accept the same and oblige. Thanking you, yours faithfully, Place : Belgaum. Date : (Dr. P.Umashankar)

Guide: Dr.I.V.UPPIN Dr.A.S.GODHI

Professor Prof & HOD

Dept. of General Surgery Dept. of General Surgery J.N.Medical College, Belgaum J.N.Medical College, Belgaum

Principal J.N.Medical College, Belgaum To,

18 | P a g e The Registrar, KLE Academy of Higher Education & Research, (Deemed University) Belgaum-590 010. Karnataka.

(Through proper channel) Sub: Institutional Ethical Clearance for the study

Respected Sir, With reference to the above, I wish to inform that my study “A STUDY TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT AGAINST PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS”- is cleared by Department of Ethical Clearance Committee and College Dissertation and Research Committee.

Thanking you, Yours faithfully, Place : Belgaum. Date : Chairman, Ethical Dissertation and Research Committee, J.N. Medical College, Belgaum-10.

From, Dr.P.UMASHANKAR

19 | P a g e Post Graduate, Department of General Surgery, J. N. Medical College, Belgaum-590 010. To, The Registrar (Evaluation) KLE Academy of Higher Education & Research, Belgaum-590010, Karnataka. (Through Proper Channel) Sub: Intimation of dissertation topic and name of guide Respected Sir, I Dr.P.Umashankar, Post Graduate in the department of General Surgery, hereby inform you that the subject chosen for my dissertation topic is “A RANDOMIZED CLINICAL TRIAL TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT VERSUS PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS”- A Randomised Clinical Trial, under the guidance of Dr.I.V.Uppin M.S, Department of General Surgery, J.N.Medical College, Belgaum. Kindly accept the same and oblige. Thanking you, Your’s faithfully

(Dr.P.Umashankar)

Guide: Dr.A.S.Godhi Dr.I.V.Uppin M.S HOD, Dept. of General Surgery Professor, Dept. of General Surgery J.N.M.C, Belgaum -590010 J.N.M.C, Belgaum. To, The Registrar KLE University,

20 | P a g e Belgaum-590010, Karnataka

(Through Proper Channel) Sub: Department of Ethical Clearance for the study

Respected Sir, With reference to the above , I wish to inform you that the project entitled “A RANDOMIZED CLINICAL TRIAL TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT VERSUS PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS”-A one year Randomised Clinical Trial, is cleared by Departmental Ethical Committee and College Dissertation and Research Committee. Thanking you, Yours faithfully, Date: Place : Belgaum Prof & HOD Dept of General Surgery J.N.Medical College, Belgaum.

Guide: Dr.I.V.Uppin M.S Professor, Dept. of General Surgery J.N.Medical College, Belgaum-590010 From, Dr. P.Umashankar Post Graduate, Department of General Surgery, J.N.Medical College, Belgaum-590 010.

21 | P a g e To, The Registrar, KLE University, Belgaum-590010, Karnataka. (Through Proper Channel) Sub : Re-Submission of Synopsis of Dissertation. Respected Sir, Herewith, I am re-submitting my synopsis of dissertation work “A STUDY TO COMPARE THE EFFICACY OF FREE OMENTAL GRAFT AGAINST PEDICLED OMENTAL GRAFT IN PREVENTION OF POST OPERATIVE LEAK IN PATIENTS WITH DUODENAL PERFORATIONS” for registration in M.S. (General surgery) of KLE University, Belgaum. The following changes have been made as per the suggestions.

1) Title modified

2) More studies quoted in literature review

3) Type of drain has been mentioned in methodology

4) Use of Proton pump inhibitors has been standardized

5) Administration of Oral contrast to all post-op patients – Not feasible

Kindly accept the same and oblige. Thanking you,

Place : Belgaum. yours sincerely, Date : (Dr. P.Umashankar)

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