A study to assess metal clips usage in laparoscopic gall bladder removal surgery
Phase 4
- Conditions
- Health Condition 1: K801- Calculus of gallbladder with othercholecystitis
- Registration Number
- CTRI/2023/05/052531
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
1. Male or Female patients aged between 18 to 60 years
2. Subjects scheduled for elective laparoscopic cholecystectomy surgery
3. Subjects willing to give written informed consent and willing to comply with all study requirements
Exclusion Criteria
1. Subjects with history of pancreatitis
2. Subjects with suspicion of gallbladder carcinoma or other metastatic diseases
3. Subjects who are pregnant or lactating at the time of surgery
4. Subjects with coagulation disorder
5. Subjects intraoperatively found to have with modified Nassar difficulty grading scale 3 4 and 5
6. Subjects whose surgical approach got converted from laparoscopic to open surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groupsTimepoint: Day of surgery, Day of discharge, Day 10 post surgery, Day 30 post surgery, Day 180 post surgery
- Secondary Outcome Measures
Name Time Method