3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Duration of surgery
Study Overview
Brief Summary
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for laparoscopic cholecystectomy
Exclusion Criteria
- •Some other surgical operation planned during LCC
- •Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
- •Operating surgeon experience less than 5 3D laparoscopy operations
Arms & Interventions
2D laparoscopic cholecystectomy
The normal laparoscopic cholecystectomy with two dimensional view
Intervention: 2D laparoscopic cholecystectomy (Procedure)
3D laparoscopic cholecystectomy
The normal laparoscopic cholecystectomy with three dimensional view
Intervention: 3D laparoscopic cholecystectomy (Procedure)
Outcomes
Primary Outcomes
Duration of surgery
Time Frame: Expected average time of surgery 1 hour
Secondary Outcomes
- Intraoperative complications(During the operation, expected average time of surgery 1 hour)
- Complications, Clavien-Dindo classification(30 days after randomization)
- Postoperative stay in hospital(Expected range 0-7 day)
- Bleeding(During the operation, expected average time of surgery 1 hour)
- Mortality(30 days after randomization)
- Need for conversion into open surgery(During the operation, expected average time of surgery 1 hour)
- Total need of opioids in milligrams(Expected range 0-7 day)
- Operation theatre time(Expected average 1,5 hours)
- Number of participants with readmission(s)(30 days after randomization)
- Postoperative pain, VAS(Expected range 0-7 day)
Investigators
Hanna Koppatz
MD
Helsinki University Central Hospital