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3D HD Versus 2D HD in Cholecystectomy

Primary Purpose

Cholelithiasis, Gall Bladder Disease

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3D HD laparoscopy
2D HD laparoscopy
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring 3D, Three-dimensional, laparoscopy, cholecystectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Herlev HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2D HD laparoscopy

3D HD laparoscopy

Arm Description

Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode

Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode

Outcomes

Primary Outcome Measures

Number of errors during the dissection of the Calot´s triangle
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.

Secondary Outcome Measures

Duration of the dissection of the Calot´s triangle
Duration of surgery
The need for conversion to open surgery
Estimated blood loss in ml
Intraoperative complications
e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.
Subjective assessment (Assessment of fatigue and perceived exertion)
The surgeon will fill out questionnaires and scales.
Subjective assessment (optical modality and mental load assessment)
The surgeon will fill out questionnaires and scales.

Full Information

First Posted
March 12, 2015
Last Updated
February 26, 2017
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396927
Brief Title
3D HD Versus 2D HD in Cholecystectomy
Official Title
Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Gall Bladder Disease
Keywords
3D, Three-dimensional, laparoscopy, cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2D HD laparoscopy
Arm Type
Placebo Comparator
Arm Description
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
Arm Title
3D HD laparoscopy
Arm Type
Active Comparator
Arm Description
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
Intervention Type
Device
Intervention Name(s)
3D HD laparoscopy
Other Intervention Name(s)
Olympus 3D ENDOEYE FLEX
Intervention Description
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
Intervention Type
Device
Intervention Name(s)
2D HD laparoscopy
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of errors during the dissection of the Calot´s triangle
Description
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.
Time Frame
Expected duration: 20 minutes
Secondary Outcome Measure Information:
Title
Duration of the dissection of the Calot´s triangle
Time Frame
Expected duration: 20 minutes
Title
Duration of surgery
Time Frame
Expected duration: 1 hour
Title
The need for conversion to open surgery
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Estimated blood loss in ml
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Intraoperative complications
Description
e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.
Time Frame
intraoperative, expected duration of surgery: 1 hour
Title
Subjective assessment (Assessment of fatigue and perceived exertion)
Description
The surgeon will fill out questionnaires and scales.
Time Frame
an expected average of 15 minutes before and after the operation
Title
Subjective assessment (optical modality and mental load assessment)
Description
The surgeon will fill out questionnaires and scales.
Time Frame
an expected average of 15 minutes after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective cholecystectomy (out-patient treatment) Exclusion Criteria: Previous upper abdominal surgery ASA-score 3 or above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Fergo
Email
charlotte.sayaka.fergo@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Fergo
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
DK2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Fergo
Email
sayakafergo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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3D HD Versus 2D HD in Cholecystectomy

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