Comparison of 4K laparoscopy with HD laparoscopy in patients undergoing laparoscopic cholecystectomy
Phase 3
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/02/040334
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
1. Adult patients > 18 years of age having symptomatic gallstones
2. ASA grade I and grade II
Exclusion Criteria
1. Acute Cholecystitis/Gangrenous Cholecystitis
2. Gallbladder malignancy
3. Prior failed attempt of laparoscopic cholecystectomy
4. Cholecystectomy combined with any additional procedure
5. Patients on immunosuppressive agents, steroids and antipsychotic drugs
6. Patienta allergic to Paracetamol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of surgery measured in minutesTimepoint: Duration of surgery measured from the time of laparoscope camera placement through the initial access port upto the time of placement of the last skin approximation suture. (Total duration of surgery will be monitored at the completion of the procedure on the day of surgery)
- Secondary Outcome Measures
Name Time Method Duration of postoperative hospitalisationTimepoint: Day of surgery will be counted as zero and calculated upto the day of discharge from the hospital;Patient satisfaction with the procedure (Five point Likert scale)Timepoint: Evaluated at 1 month following the procedure;Perception of operative difficulty by the trainee surgeons (three severity grades)Timepoint: During the procedure of laparoscopic cholecystectomy;Post operative pain scores (visual analogue scale)Timepoint: 06 hours, 12 hours, 24 hours, 1 week, 1 month;Proportion of patients having intra operative adverse events during Laparoscopic cholecystectomy (Injury to bile duct, bowel, right hepatic artery, gallbladder perforation)Timepoint: During the surgical procedure;Proportion of patients requiring to open procedureTimepoint: During the procedure of laparoscopic cholecystectomy