3D HD Versus 2D HD in Cholecystectomy

NCT ID: NCT02396927

Last Updated: 2017-02-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Cholelithiasis Gall Bladder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2D HD laparoscopy

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

Group Type PLACEBO_COMPARATOR

2D HD laparoscopy

Intervention Type DEVICE

Placebo

3D HD laparoscopy

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

Group Type ACTIVE_COMPARATOR

3D HD laparoscopy

Intervention Type DEVICE

Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.

Interventions

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3D HD laparoscopy

Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.

Intervention Type DEVICE

2D HD laparoscopy

Placebo

Intervention Type DEVICE

Other Intervention Names

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Olympus 3D ENDOEYE FLEX

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous upper abdominal surgery
* ASA-score 3 or above
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Fergo

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Fergo

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Charlotte Fergo

Role: CONTACT

Facility Contacts

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Charlotte Fergo

Role: primary

Other Identifiers

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3D_vs_2D_chol

Identifier Type: -

Identifier Source: org_study_id

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