3D vs 2D HD Laparoscopy in Cholecystectomy

August 27, 2017 updated by: Hanna Koppatz, Helsinki University Central Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of surgery
Time Frame: Expected average time of surgery 1 hour
Expected average time of surgery 1 hour

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Incisional hernias
Time Frame: after 1, 5 and 10 year
after 1, 5 and 10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Chair: Ville Sallinen, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 10, 2017

Study Completion (Actual)

May 10, 2017

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 27, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUCH-328-150127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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