Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis

NCT06969144 | Completed DMC

• 1 other identifier: 416(6-11)E2,081/82
• Study Type: observational
• Target: 1,149
• Locations: 1 country
• Sites: 1

Brief Summary

Subtotal cholecystectomy (STC) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. It helps reduce the risk of bile duct injuries and other complications that arise during a total cholecystectomy (TC) when these structures are not visible. This study evaluates the safety and outcomes of subtotal cholecystectomy in chronic cholecystitis.

Conditions

Gallstone

Outcome Measures

Primary Outcomes (1)

• postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC)

  The primary outcome was to assess the postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC) groups.

  upto 22 months

Interventions

cholecystectomy PROCEDURE

The indications for elective cholecystectomy were symptomatic cholelithiasis, a GB polyp more than ten millimeters, a history of cholecystitis, biliary pancreatitis, or choledocholithiasis. Patients with cholecystitis and severe or moderately severe pancreatitis were operated on after six weeks of the event. Other patients received surgery at the earliest available date. All patients with choledocholithiasis underwent endoscopic retrograde cholangiopancreatography (ERCP) and stone clearance before cholecystectomy. Patients who underwent laparoscopic cholecystectomy were evaluated by surgical and anesthesia teams in outpatient clinics and co-morbid conditions were optimized. Preoperative antibiotic prophylaxis was given to all the patients before induction of anesthesia.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing laparoscopic cholecystectomy

You may qualify if:

• Clinical diagnosis of cholelithiasis planned for laparoscopic cholecystectomy
• Clinical diagnosis of gallbladder polyp planned for laparoscopic cholecystectomy

You may not qualify if:

• Gall bladder malignancy
• Cholelithiasis and gallbladder polyp cases managed non-operatively
• additional procedures along with cholecystectomy like bile duct exploration, bile duct excision for choledochal cyst.

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Study Sites (1)

Tribhuvan University Teaching Hospital, Kathmandu, Nepal

Kathmandu, 44600, Nepal

Location

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: May 13, 2025
• Study Start: December 23, 2024
• Primary Completion: January 12, 2025
• Study Completion: January 13, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: as supplementary file
• Access Criteria: as supplementary file

Locations

NE (1)