3D vs 2D HD Laparoscopy in Cholecystectomy

Not Applicable

Completed

• Conditions: Cholecystolithiasis
• Interventions: Procedure: 2D laparoscopic cholecystectomy; Procedure: 3D laparoscopic cholecystectomy

• Registration Number: NCT02357589
• Lead Sponsor: Helsinki University Central Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Primary Completion: 2017-05-10
• Study Completion: 2017-05-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-27
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D laparoscopic cholecystectomy	2D laparoscopic cholecystectomy	The normal laparoscopic cholecystectomy with two dimensional view
3D laparoscopic cholecystectomy	3D laparoscopic cholecystectomy	The normal laparoscopic cholecystectomy with three dimensional view

Primary Outcome Measures

Name	Time	Method
Duration of surgery	Expected average time of surgery 1 hour

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	During the operation, expected average time of surgery 1 hour	Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland