A comparison of time taken for gallbladder removal surgery (cholecystectomy) by two methods (conventional laparoscopic technique versus fluorescent laparoscopic technique) in patients of gallbladder stone disease.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/05/067266
- Lead Sponsor
- Dr Subhajit Datta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients undergoing laparoscopic cholecystectomy surgery.
Exclusion Criteria
1. Jaundice.
2. Gall bladder malignancy.
3. Pregnancy
4. Any deviation from the proposed procedure of laparoscopic cholecystectomy.
5. Equipment failure effecting the duration of surgery.
6. Contraindications to the use of indocyanine green dye including known allergy to the agent.
7. Pre-existing medical conditions or surgical history that may significantly impact the operative time or compromise patient safety.
8. Conversion to open cholecystectomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of surgery in minutes (from first incision/ port to closure of last incision/ port)Timepoint: at the start and at the end of the surgery (closure of the last port)
- Secondary Outcome Measures
Name Time Method 1. Various complications of ICG dye administration <br/ ><br>2. Difference in time taken during different surgical steps <br/ ><br> a. Time duration from gallbladder retraction to dissection of Calot’s triangle <br/ ><br> & achievement of Strassberg’s critical view of safety <br/ ><br> b. Time duration from cystic duct division to dissection of gallbladder from <br/ ><br> liver bed <br/ ><br> 3. Subgroup analysis of difference of operative duration between techniques based <br/ ><br> on anthropometry, demography, sonological findings & Nassar & Cuschieri <br/ ><br> difficulty grades.Timepoint: 1. During & after the surgery (for first secondary outcome) <br/ ><br>2. At the start, during & at the end of the surgery (for second secondary outcome) <br/ ><br>3. During analysis (Post-hoc analysis) (for 3rd secondary outcome)