Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.

Completed

• Conditions: Cholecystectomy; Cholelithiasis; Laparoscopic Cholecystectomy

• Registration Number: NCT05366907
• Lead Sponsor: Chitwan Medical College

Brief Summary

In the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstone disease. The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care center.

Detailed Description

Laparoscopic Cholecystectomy (LC) is the gold standard surgery for symptomatic cholelithiasis with low mortality and morbidity.1,2 However, 1% to 15% of conversion rate to Open Cholecystectomy (OC) during laparoscopic cholecystectomy has been reported.3 Converted cases were associated with increased perioperative time, complication rates, perioperative costs, the length of hospital stay, and a higher 30-day readmission rate.3,4 Conversion was also associated with complications including bile leak, bile duct injury, or bleeding, requiring reoperation or transfusion, and death. A recent detailed critical review found that preoperative variables like male gender, older age, high body mass index, previous abdominal surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with the higher rate of conversion to OC.4 However, data regarding its prevalence lacking in our setting.

The aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care centre.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-30
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• All the cases of Symptomatic Cholelithiasis elected for Laparoscopic Cholecystectomy

Exclusion Criteria

• Age <10 years,
• Gall Bladder Malignancy,
• Adults with preoperative choledocholithiasis, and
• Perforated gall bladder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laparoscopic to Open cholecystectomy	1 year	Demographic details, previous attack of biliary pathology, underlying condition, Huang classification of the biliary system are collected. And conversion rate among these patients were calculated with CR= number of converted surgeries/(number of converted surgeries + number of LC surgeries) × 100) Objectives- To identify the prevalence of conversion rate and, To compare the CR among independent variables- Age, Sex, history of previous attack with dependent variable Open cholecystectomy.

Trial Locations

Locations (1)

Chitwan Medical College Teaching Hospital; 🇳🇵 Bharatpur, Bagmati, Nepal