RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the candidate and address (in block letters) / : / DR. SYED NADEEM AHMED, P.G. IN DEPT OF SURGERY MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA-585 105
Permanent address / : / DR. SYED NADEEM AHMED, C/O ABDUL RAHEEM NO: 79, Vth MAIN MINHAJ NAGAR KADIRENAHALLI, J.P. NAGAR POST: BANGALORE-78
2 / Name of the Institution / : / H.K.E. SOCIETY’S MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA-585 105
3 / Course of Study and Subject / : / M.S. (GENERAL SURGERY)
4 / Date of admission to the course / : / 13th September 2011.
5 / Title of the Topic / : / “COMPREHENSIVE ANALYSIS OF ENTERO CUTANEOUS FISTULAE ”
6 / Brief Resume of the intended work / :
6.1 / Need for the study
Entero Cutaneous Fistulae(ECF) are one of the most dreaded complications following intra abdominal surgeries. They remain among the most difficult condition in surgery to manage, mainly because of multiple factors for genesis of fistula and non-healing of fistula.
This leads to increased morbidity i.e., associated with surgical procedure or the primary disease increases, affecting the patients quality of life, lengthening his/her hospital stay, and raising the overall cost for the treatment. And mortality, ranging from 5-20% due to associated sepsis, nutritional abnormality and electrolyte in balances.(1)
Hence, I decided to study comprehensively the etiology, and factors prognosticating its outcome, so that its incidence could be decreased and maximum adequate latest management could be instituted
6.2 / Review of Literature
Study of entercutaneous fistula araising from GIT,by Edmunds et al provided a comprehensive discussion of ECF. Of 157 patients in the study ,67 developed ECF following surgery. Mortality was 62% in patients with gastric and duodenal fistulas, , 54% in patients with small bowel fistulas, and 16% with colonic fistulas (1)
The Challenge of Enterocutaneous Fistulae- Col Rajan Chaudry. During period of six years 17 cases of ECF arising from the small intestine were managed. 76% ECF resulted from surgical complications. Only one fistula (6%) closed spontaneously. There were 2deaths (12%) and 82% required surgical intervention at some stage for successful closer of intestinal fistula. Conclusion Aggressive surgical treatment with judicious use of octreotide, nutritional support and control of sepsis significantly improves the outcome of small intestinal fistula. (4,7)
Enterocutaneous fistulae: Etiology, Treatment, and outcome-A Study from South India. Kumar P, Maroju NK, et al.
A total of 41 patients were included in this prospective observational study. 95% of ECF were postoperative. Ileum was found to be the most common site of ECF. Surgical intervention was required in 41% of patients. Conclusion most of the ECF are encountered in the postoperative period. Serum albumin levels can predict fistula healing and mortality. Conservative management should be the first line of treatment. Mortality in patients with ECF continues to be significant and is commonly related to malnutrition and sepsis. (2,7)
Metabolic and Nutritional Support of the Enterocutaneous Fistula Patient:A Three-Phase Approach. Polk TM, Schwab CW The care and outcome of enterocutaneous fistula (ECF) have improved greatly over several decades due to revolutionary advances in nutrition, along with dramatic improvements in the treatment of sepsis and the critically ill. Enteroatmospheric fistula (EAF) in the “Open abdomen” patient has emerged as an even more vexing problem. Conclusion:- Agrressive nutritional therapy is necessary to reverse the catabolic state associated with ECF/EAF patients. Once established, it allows proper time, preparation for definitive management of the fistula, and in many cases provides the support spontaneous closure. (8)
Factors Predictive of Recurrence and Mortality after surgical Repair of Enterocutaneous Fistula. Martinez JL, Luque-de-Leon et al. Total of 71 Patients were there in study ECF recurred in 22 patients (31%) 18 of them (82%) eventually closed with medical and or surgical treatment. (9)
Treatment of enterocutaneous fistula with total parenteral feeding in comination with octreotide: a case report. Fekaj E, Salihu L, Morina A. Case Presentation:-A 50 year Old women patient underwent four surgical interventions, After fourth surgical intervention, at eighth post-operative day ECF developed on 20th day, after ECF develop together with TPN octreotide (100 mcg/8 hrs) for 48 hrs. Conclusion:- The fistula output, after treatment of TPN in combination with octreotide, compared with the treatment only with TPN wasn’t significant, in our case, (p<0,05). We think that the optimum time for surgical treatment should not be based only on the period of time of conservative treatment, but other factors should be taken on consideration like the pathology that has indicated the surgical treatment, the number of surgical interventions and period of time between these interventions. (3,10)
Complications of enterocutaneous fistulas and their management, Williams LJ, Zolfaghari S, Boushey RP. Complications related to enterocutaneous fistulas are common and include sepsis, malnutrition, and fluid or electrolyte abnormalities. Intestinal failure is one of the most feared complications of enterocutaneous fistula management and results in significant patient morbidity and mortality. (11)
Enterocutaneous fistula: a single-centre experience. Gyorki DE, Brooks CE et al. A total 33 patients were identified with ECF, The aetiology was Crohn’s (30%) anastomotic leak (24%), iatrogenic (18%), mesh (6%), and other (16%). Definitive surgery was undertaken in 21 (64%) following presentation, Twenty percent patients required emergency surgical intervention and 5 percent required pre-operative TPN. Conclusion:- Patients with ECF can be treated with low morbidity and low recurrence rate in a multidisciplinary setting. We believe that patients with ECF should be referred to specialist units for management. (12)
6.3 / Objective of the Study
1.  To study Epidemiology,
2.  To Study Aetiology.
3.  To Study Prognosticating factors influencing outcome.
4.  To compare Conservative vs Surgical management,
5.  To Study complications.
6.  To find outcome of Entero cutaneous Fistulae.
7 / Materials and methods
7.1 / Source of data.
All patients with intra abdominal surgeries presenting with, or develop enterocutaneous fistula managed at MRMC’s Basaveshwar Teaching & General Hospital between period of December-2011 to July-2013 included in the study and the study will be carried out till the required sample size of fourty cases is fulfilled.
7.2 / Methods of collection of Data (including sampling Procedure, if any)
Methods:-
Purpose of study will be explained to the patients and their attenders,all the cases presented/develop with enterocutaneous fistula would be admitted and managed in Basaveshwar Teaching Hospital will be evaluated by using pre-structured Pre-Tested proforma
Place of Study:-
Basaveshwar Teaching & General Hospital Gulbarga
Duration of Study:-
For a Period of 20 Months. From December-2011 to July-2013
Sample size and design:
Initially a minimum of 40 cases are intended to be taken up, how ever scope of increasing the number of case also exists depending upon study pattern.
Design:- A prospective study.
Inclusion Criteria:-
This includes patients with gastric, duodenal, small bowel and colic fistula.
Exclusion Criteria
This excludes oropharyngeal, pancreato biliary and anal fistula.
7.3 / Does the study require any investigation or intervention to be conducted on patients or other human or animals? If so please describe briefly.
Yes,
·  Labouratory,Investigations:-Haemoglobin(gm/dl)-Daily, Body Weight- Daily, Nitrogen balance-Daily,
·  Serum albumin-Twice a week, Arm-Circumference-Weekly, Serum folate, iron, mg, zn-Weekly, Serum Mn, Cu,B 12-Monthly.
·  Special investigation like
·  Contrast study, Fistulography, USG abdomen, Endoscope.
·  Wound Swabs, Urine c/s, Sputum c/s, blood c/s, Pus c/s.
·  Blood-Haematocrit, Serum-Sodium, Potassium, Chloride, Urea, glucose, Creatinine-Daily.
·  Urine-Volume,/24 hrs, Fistula-Volume/24 hrs.- Daily.
7.4 / Has ethical clearance been obtained from your institution in case of 7.3?
Yes, Ethical clearance has been obtained from research and dissertation committee/ethical committee of the institution for this study.
8 / List of Reference
1.  Edmunds LH Jr, Williams GH, Welch CE. External fistulas arising from the gastro intestinal tract. Ann Surg. Sep 1960; 152,445-71.
2.  Fischer JE. The path physiology of enterocutaneous fistulas. World J Surg. 1983;7:446-50.
3.  Martineau P, Shwed JA. Denis R. Is octerotide a new hope for enterocutaneous and external fistula closure? Am J surg 1996;172:386-95.
4.  Campos AC, Andrade DF, Campos GM, et al. A multivariate model to determine prognostic factors in gastrointestinal fistulas. J Am Coll Surg. May 1999;188(5):483-90.
5.  Fischer JE. Gastrointestinal-cutaneous fistulae. In: Baker RJ, Fischer JE, eds. Mastery of Surgery. 4th ed. Philadelphia, PA:Lippincott Williams & Wilkins;2001:1435-41.
6.  enterocutaneous fistula page no: 184 to 197 maingot’s abdominal operations 11th addition.
7.  Enterocutaneous fistulae: Etiology, treatment, and outcome-A study from South India. Kumar P, et al. Department of Surgery Jipmer, Pondicherry, India.
8.  World J Surg. 2011 Oct 28. A Metabolic and Nutritional support of the Enterocutaneous Fistula Patient-A Three-Phase approach. Division of Traumatology University of Pennsylvania, Philadelphia.
9.  J Gastrontest surg. 2011 Oct 15. Factors Predicitive of Recurrence and Mortality after Surgical repair of Enterocutaneous Fistula, UMAE hospital, Mexico, DF, CP 06725.
10. Cases J. 2009 Oct-30;2:177. Treatment of enterocutaneous fistula with total parental feeding in combination with octreotide, University of Clinical center of Kosova, Prishtina 10000, Republic of Kosova.
11. Complications of enterocutaneous fistula and their management University of Ottawa, Ontario, Canada.
12. ANZ J Surg. 2010 Mar;80(3):178-81. Enterocutaneous fistula a single centre experience.
9. / Signature of Candidate
10. / Remarks of the Guide / Enterocutaneous fistula is a common postoperative complication after abdominal surgery, which requires specialized management. Hence this study has been selected to improve the mortality and morbidity.
11. / Name and Designation of (in block letters)
11.1 / Guide / Dr. V.S.KAPPIKERI
M.S.,
Associate Professor
Department of Surgery
M.R. Medical College, Gulbarga.
11.2 / Signature
11.3 / Co-Guide(if any)
11.4 / Signature
11.5 / Head of the Department / Dr. S.A.HALKAI
M.S.,
Professor & Head of the
Department of Surgery.
M.R. Medical College, Gulbarga.
11.6 / Signature
12 / 12.1 / Remarks of the Dean and Principal
12.2 / Signature