RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |Name of the Candidate and Address |Dr. Yadhu K.L. |

| |(in block letters) |S/o Dr. K.V. LOKANATH |

| | |# 462, 7TH CROSS, 8TH MAIN, |

| | |P.J. EXTENSION, |

| | |DAVANGERE – 577 002. |

|2. |Name of the Institution |J.J.M. MEDICAL COLLEGE, |

| | |DAVANGERE-577004. |

|3. |Course of Study and Subject |POST GRADUATE |

| | |M.S. IN GENERAL SURGERY |

|4. |Date of admission to Course |01-06-2010 |

|5. |Title of the Topic |“Comparative study of Single LAYER VERSUS Double Layer Anastomosis of |

| | |small and large bowel” |

|6. |Brief resume of the intended work |

| |6.1 Need for the study: |

| |Asepsis, haemostasis, gentleness to tissue are the basis of surgeon’s art. Intestinal anastomosis has been excited interest in |

| |our day to day surgical practice since its beginning. The technique of resection and anastomosis since the inception has been |

| |experimentally evolved for better and efficient healing of anastomotic site. Intestinal anastomosis is very commonly performed |

| |technique in today’s surgical era. Number of techniques have been devised at different times yet there is no single technique |

| |which is internationally accepted.1 |

| |The creation of anastomosis for various clinical condition of small and large bowel is a major task in daily practice of surgery. |

| |Intestinal continuity can be restored by use of stapling devices, tissue glue, suture-less bio fragmentable ring, fibrin Glue |

| |(saint), laser welding devices, compression anastomotic clips, ring made up of nithinol, compression anastomotic ring locking |

| |procedure (CARP), hand sewn double layer suturing technique and single layer suturing technique by using different types of suture|

| |materials. |

| | In today’s cost conscious environment the use of staples for intestinal anastomosis does not suit common man as these staples |

| |are very expensive and should be used with caution and needs great surgical experience. But hand sewn anastomosis can be done in |

| |an appropriate time and can be performed at a lesser cost to suit the economy of common man. Hand sewn suturing technique remains |

| |the main stay for intestinal anastomosis in developing countries like India and is proven successful in most bowel surgery. |

| |This comparative study endeavors to compare outcome of single layer versus double layer intestinal anastomosis in small and large |

| |bowel in terms of duration required to perfom intestinal anastomosis, post operative complications like anastomotic leak and cost |

| |effectiveness.2,3,4 |

| |6.2 Review of Literature : |

| |The word anastomosis comes from a Greek word Anastomoo meaning to “furnish with a mouth”. Literally anastomosis is a surgical |

| |connection between the two structures. |

| |The first surgical anastomosis was performed by Jean Reybord in Lyon. |

| |According to descriptive study at Lady Reading Hospital, Peshawar in 2006, single layer serosubmucosal (extramucosal) technique is|

| |safe, easy to perform, simple to teach and with less anastomotic related morbidity and mortality.5 |

| |According to a comparative study at Saidu Group of Teaching Hospital, Swat in 2003, 1 out of 52 patients in single layer technique|

| |developed leakage and 8 out of 61 patients in double layer technique developed leakage.6 |

| |A meta anlaysis of randomized controlled trials at Kyoto prefectural university of medicine, Japan in 2006 clarified that |

| |considering duration of the anastomosis procedure and medical expenses, single layer intestinal anastomosis may prove the optimal |

| |choice in most surgical situations.4 |

| |According to prospective study at Dow University of Health Sciences & Civil Hospital, Karachi in 2009, single layer interrupted |

| |extra mucosal intestinal anastomosis can be constructed in less time with minimal complication compared with two-layered |

| |technique.1 |

| |According to a case controlled study at Ahwaz Educational Hospitals in 2006 Single layer anastomosis is safe; complications of |

| |single layer anastomosis are similar to double layer anastomosis; in addition operation time and total cost with the single layer |

| |technique were found to be decreased.2 |

| |A comparative study at Allied Hospital, Faisalabad revealed average time for the construction of the single layer anastomosis was |

| |20 minutes and in double layer was 35 minutes, leakage rate waste 12% in double layer and 6% in single layer. More over structure |

| |material consumption was more in two layer technique when comparative single layer technique.3 |

| |6.3 Objectives of the study: |

| |To compare duration required to perform single and double layered intestinal anastomosis. |

| |To study post operative complications like anastomotic leak in single and double layered intestinal anastomosis. |

| |To compare cost effective of suture material used in single and double layered intestinal anastomosis. |

|7. |Materials and methods: |

| |7.1 Source of data: |

| |Data will be collected from patients who come to Chigateri General Hospital and Bapuji Hospital, Davangere attached to J.J.M. |

| |Medical College, Davangere, who require intestinal resection and anastomosis for comparative study from June 2010 to May 2012(2 |

| |Years). |

| |7.2 Method of collection of data :( including sampling procedure if any) |

| |Sampling procedure: |

| |The patients selected for this study are those who are admitted with various clinical conditions requiring resection and anastomosis |

| |of small and large bowel. |

| |Based on detailed history, thorough clinical examinations, radiological examinations and USG abdomen, the diagnosis will be made. |

| |These patients will be subjected to the required pre operative investigations; after bowel preparation, ensuring fitness elective |

| |surgery will be done. |

| |Cases will be allotted to either groups alternatively requiring single layer anastomosis and double layer anastomosis for various |

| |clinical conditions as and when they get admitted. Intestinal anastomosis will be carried out in single layer continuous extramucosal|

| |technique with 2-0 vicryl and double layer continuous technique with 2-0 vicryl taking through all layers and seromucusular layer |

| |with 3-0 mersilk. |

| |Each case will be analyzed with respect to duration required to perform intestinal anastomosis, post operative complications like |

| |anastomotic leak and cost effectiveness of suture material. |

| |All cases will be followed up to discharge and subsequently for a follow up period of 2 weeks Each case will be analyzed with respect|

| |to duration required to perform intestinal anastomosis, postoperative complications like anastomotic leak and cost effectiveness of |

| |suture material. |

| |A minimum of 60 cases with the following inclusions and exclusion criteria will be selected for the study and will be allocated |

| |alternatively to each of the comparative study. |

| |Inclusion criteria : |

| |Age criteria 20-60 years. |

| |Elective surgical procedure for various clinical conditions requiring resection and anastomosis of small or large bowel. |

| |Anastomosis done by extramucosal single layer continuous technique or double layer continuous technique. |

| |Exclusion criteria : |

| |Patient not undergoing surgical treatment. |

| |Age less than 20 years and more than 60 years. |

| |Emergency resection and anastomosis of small and large bowel. |

| |Anastomosis carried out by interrupted by single or double layer technique |

| |A pretested proforma will be used to collect relevant information (patient data, clinical findings, lab investigations, follow up |

| |events etc.,) from all the selected patients. |

| |Statistical analysis : |

| |Comparison between the two groups will be done by Z test for proportions / Fisher’s exact test. |

| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please|

| |describe briefly: |

| |Yes |

| |Investigations: |

| |Routine: |

| |Hb % , TC, DC, ESR, |

| |Random blood sugar, blood urea, serum creatinine |

| |HIV, HbsAg, |

| |Urine Routine examination |

| |Plain X Ray Abdomen |

| |ECG |

| |USG Abdomen |

| |Special: |

| |Barium Meal follow through |

| |Barium Enema |

| |Colonoscopy |

| |Fistulogram |

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

| |Yes |

| | |

|8. |List Of References: |

| |Ayub M, Sheikh R, Gangat S, Rehman A. Single layer versus two layer intestinal anastomosis – a prospective study. Pakistan J Surg |

| |2009;25(3):141-143. |

| |Askarpour S, Sarmast MH, Peyvasteh M, Gholizadeh B. Comparision of single and double layer intestinal anastomosis is Ahwaz hospitals |

| |(2005-2006). Internet J Surg 2010;23(2). |

| |Khan RAA, Hameed F, Ahmed B, Dilawaiz M, Akram M. Intestinal anastomosis; comparative evaluation of safety, cost effectiveness, |

| |morbidity and complication of single versus double layer. Professional Med J 2010June;17(2);232-234. |

| |Shikata S, Yamagishi H, Taji Y, Shimada T, Noguchi Y. Single-versus two-layer intestinal anastomosis: a meta analysis of randomized |

| |controlled trials. BMC Surg 2006;6:2. |

| |Khan N, Rahman A, Sadiq M. Single layer interrupted serosubmucosal (Extral mucosal) intestinal anastomosis. J Med Scie |

| |2006Jan;14(1):10-13. |

| |Samiullah, Israr M, Zada N. Comparision of single layer interrupted intestinal anastomosis with double layer intestinal anastomosis. |

| |J Postgrad Med Inst 2003 Apr–Jun;17(2):263-6. |

| | | |

|9. |Signature of Candidate | |

| | |The technique of intestinal resection and anastomosis has evolved over the |

|10. |Remarks of Guide |past 200 years. Despite all the advances, hand sewn technique has stood the |

| | |test of time. Double layer, later single layer extramucosal anastomosis are |

| | |safe and cost effective. This study attempts to compare the two techniques. |

| | | |

|11. |Name and Designation of | |

| |(In Block Letters) | |

| |11.1 Guide |Dr. Deepak G. Udapudi M.S. |

| | |PROFESSOR, |

| | |Department of GENERAL Surgery, |

| | |J.J.M. Medical College, |

| | |Davangere – 577 004. |

| | | |

| |11.2 Signature | |

| | | |

| | | |

| |11.3 Co-Guide (If any) | |

| | |None |

| | | |

| |11.4 Signature | |

| | | |

| | | |

| |11.5 Head of Department |Dr. R.L. Chandrashekar M.S., |

| | |Professor and H.O.D., |

| | |Department of GENERAL Surgery, |

| | |J.J.M. Medical College, |

| | |Davangere – 577 004. |

| | | |

| | | |

| |11.6 Signature | |

| | | |

|12. |12.1 Remarks of the Chairman and Principal | |

| | | |

| | | |

| |12.2 Signature | |

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