Protocol and thesis progress submission report

Thesis progress report submission .

1. “ To Predict the preoperative factors for bile duct injury-Retrospective and Prospective Study” SUPERVISOR- PROF DR U. K. CHANDEL PROFESSOR (HOD) DEPT OF GENERAL SURGERY IGMC, SHIMLA CO-SUPERVISOR- DR VIPAN KUMAR SHARMA ASSISTANT PROFESSOR DEPT OF GENERAL SURGERY (SURGICAL GASTROENTEROLOGY) IGMC, SHIMLA

2. AIMS AND OBJECTIVE Primary Objective : To identify preoperative factors which leads to Bile duct injury. Secondary objective : a)To identify pattern of Bile duct injury in patients of open/laparoscopic cholecystectomy. b)To identify pattern of time of presentation of BDI in post operative period of patients of open/laparoscopic cholecystectomy.

3. MATERIALS AND METHODS Study area and study population:  Department of Surgery in Indira Gandhi Medical College and Hospital, Shimla, Himachal Pradesh. Study design:  Cross sectional observational study with retrospective data collection from clinical records and prospective data collection during study period.

4. Study duration: Prospective-  1 year from March 2023 to Feb 2024 Retrospective- 1year from January 2022 to Feb 2023 Inclusion criteria: ​ All post open/laparoscopic cholecystectomy patients of age above 18 years with bile duct injury presenting to IGMC, Shimla during January 2022 to February  2024.   Exclusion criteria:  All known diagnosed cases of CA GB

5. All cases with asymmetrically thick walled GB All cases of xanthogranulomatous GB Factors to be studied: Factors to be studied are classified as Preoperative factors Age Gender

6. Co morbidities- Hypertension / CAD / Diabetes mellitus GSD- Symptomatic/incidental Episodes of cholecystitis Previous abdominal surgery Per op USG – GB/ Stone/ CBD/ IHBRD condition Pre op LFT

7. Per op ERCP Pre op MRCP Post operative factors Time of presentation of bile leak Post op ERCP Post op MRCP Post op LFT Type of bile duct injury

8. Sample size: All the cases of open/laparoscopic cholecystectomy of age 18years or more presenting to IGMC, Shimla Prospective -March 2023 to February 2024. Retrospective -January 2022 to February 2023.   Method and Materials: After retrospective and prospective data collection association of categorical variables with outcome i.e. bile duct injury would be analysed by using Fisher’s exact test or chi square test, whichever is applicable and continuous variables would be analysed using Independent T-test or Mann Whitney U test depending upon normality of data. ODD’s Ratio with 95% confidence interval would be calculated in uni -variate analysis as a measure of association of categorical variables with outcome. Two tailed significance test would be used for all statistical analysis. P-value < 0.05 would be considered as statistically significant.