Comparision of cholecystectomy using laparoscopy vs mini-laparoscopy as a day care procedure

Phase 3

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/09/057858
• Lead Sponsor: Maulana Azad Medical College and Associated Lok Nayak Hospital

Brief Summary

This is a randomized controlled study designed to compare mini-laparoscopic(MLC) and conventional laparoscopic cholecystectomy(CLC) as a daycare procedure in terms of difference in operative time, intraoperative occurrences and post operative outcomes including cosmesis in a single center in New Delhi, India. The primary outcome measures will be operative time and conversion of MLC/CLC to CLC/Open Cholecystectomy, as recorded at the completion of procedure. The secondary outcomes will be intraoperative events, post operative complications, post operative pain using VAS score and Cosmetic outcome. The secondary outcomes will be recorded at post operative day 1,3,7 and at 1 month.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients eligible for day care surgery.
• (as per ASA guidelines for Ambulatory Anesthesia and Surgery.

Exclusion Criteria

• History of cholecystitis (Biliary colic lasting for >24hours or requiring hospitalization) within 2months 2.
• History of previous upper abdominal surgeries 3.
• Coagulopathies 4.
• Morbid Obesity 5.
• Choledocholithiasis 6.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Operative time	At the time of completion of Procedure (skin closure)
2. Conversion of MLC/CLC to CLC/ Open cholecystectomy	At the time of completion of Procedure (skin closure)

Secondary Outcome Measures

Name	Time	Method
1. Intraoperative events [for e.g., bleeding, bile duct injury, gall bladder perforation, bowel injury etc.]	During Procedure
2. Post operative complications [for e.g., fever, bile leak, surgical site infection]	Post operative day 1,3,7 and at 1 month
3. Post operative pain using Visual Analogue Scale (VAS) score	At 2,4,6,8,24,72 hour from surgery and at post operative day 7
4. Cosmetic outcome [measured as, average of Stony Brook Scar Evaluation Scale score (SBSES) of all the port sites by the investigator, and with a self-assessment scale for cosmetic results of 1 (not satisfied at all) to 5 (extremely satisfied) by the patient themselves	At 1 month after operation

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Lok Nayak Hospital

🇮🇳Central, DELHI, India

Dr Harsha

Principal investigator

9468013094

Harshajoon@gmail.com