A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 524
- Locations
- 1
- Primary Endpoint
- Duration of the operation
Study Overview
Brief Summary
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
Detailed Description
More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
The study has two analyses:
- at 6 month follow up
- at 24 months follow up
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged > 18 years
- •Patients eligible for LC during the study period
Exclusion Criteria
- •refused to participate
Outcomes
Primary Outcomes
Duration of the operation
Time Frame: 1 hour
Duration of the operation in minutes
Number of participants with Conversion to open surgery
Time Frame: 1 hour
Number of participants with Failure of the technique and conversion to open surgery
Incidence of intra operative visceral injury
Time Frame: 2 hours
Incidence of intra operative visceral injury
intra operative amount of blood loss
Time Frame: 2 hours
intra operative amount of blood loss in ml
incidence of intra operative complications
Time Frame: 2 hours
incidence of intra operative complications
Secondary Outcomes
- post operative stay(1 week)
- incidence of port site infection(1 month)
- Incidence of port site hernia(24 months)