3D vs 2D HD Laparoscopy in Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-10

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).

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Detailed Description

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Conditions

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Cholecystolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2D laparoscopic cholecystectomy

The normal laparoscopic cholecystectomy with two dimensional view

Group Type ACTIVE_COMPARATOR

2D laparoscopic cholecystectomy

Intervention Type PROCEDURE

3D laparoscopic cholecystectomy

The normal laparoscopic cholecystectomy with three dimensional view

Group Type EXPERIMENTAL

3D laparoscopic cholecystectomy

Intervention Type PROCEDURE

Interventions

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2D laparoscopic cholecystectomy

Intervention Type PROCEDURE

3D laparoscopic cholecystectomy

Intervention Type PROCEDURE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No