3D vs 2D HD Laparoscopy in Cholecystectomy

Study Overview
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Brief Summary
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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).

Official Title
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3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial

Conditions
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Cholecystolithiasis

Intervention / Treatment
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* Procedure: 2D laparoscopic cholecystectomy
* Procedure: 3D laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D laparoscopic cholecystectomy<br>The normal laparoscopic cholecystectomy with two dimensional view | Procedure: 2D laparoscopic cholecystectomy<br> <br> |
| Experimental: 3D laparoscopic cholecystectomy<br>The normal laparoscopic cholecystectomy with three dimensional view | Procedure: 3D laparoscopic cholecystectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | Expected average time of surgery 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for conversion into open surgery |  | During the operation, expected average time of surgery 1 hour | 
| Intraoperative complications | Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture | 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 | 
| Number of participants with readmission(s) |  | 30 days after randomization | 
| Total need of opioids in milligrams |  | Expected range 0-7 day | 
| Mortality |  | 30 days after randomization | 
| Operation theatre time |  | Expected average 1,5 hours | 
| Postoperative pain, VAS |  | Expected range 0-7 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, laparoscopy, cholecystectomy