3D HD Versus 2D HD in Cholecystectomy

February 26, 2017 updated by: Charlotte Fergo, Herlev Hospital

Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.

The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.

Study Type

Interventional

Enrollment (Anticipated)

30

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

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective cholecystectomy (out-patient treatment)

Exclusion Criteria:

  • Previous upper abdominal surgery
  • ASA-score 3 or above

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2D HD laparoscopy
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
Device: 2D HD laparoscopy
Placebo
Active Comparator: 3D HD laparoscopy
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
Device: 3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
Other Names:
  • Olympus 3D ENDOEYE FLEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of errors during the dissection of the Calot´s triangle
Time Frame: Expected duration: 20 minutes
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
Expected duration: 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the dissection of the Calot´s triangle
Time Frame: Expected duration: 20 minutes
Expected duration: 20 minutes
Duration of surgery
Time Frame: Expected duration: 1 hour
Expected duration: 1 hour
The need for conversion to open surgery
Time Frame: intraoperative, expected duration of surgery: 1 hour
intraoperative, expected duration of surgery: 1 hour
Estimated blood loss in ml
Time Frame: intraoperative, expected duration of surgery: 1 hour
intraoperative, expected duration of surgery: 1 hour
Intraoperative complications
Time Frame: intraoperative, expected duration of surgery: 1 hour
e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.
intraoperative, expected duration of surgery: 1 hour
Subjective assessment (Assessment of fatigue and perceived exertion)
Time Frame: an expected average of 15 minutes before and after the operation
The surgeon will fill out questionnaires and scales.
an expected average of 15 minutes before and after the operation
Subjective assessment (optical modality and mental load assessment)
Time Frame: an expected average of 15 minutes after the operation
The surgeon will fill out questionnaires and scales.
an expected average of 15 minutes after the operation

Collaborators and Investigators

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

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Charlotte Fergo, Herlev Hospital

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

March 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 26, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D_vs_2D_chol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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