3D HD Versus 2D HD in Cholecystectomy

Herlev Hospital

Status: Unknown

Conditions: Gall Bladder Disease; Cholelithiasis

Treatments: Device: 2D HD laparoscopy; Device: 3D HD laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02396927

3D_vs_2D_chol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

2D HD laparoscopy

Placebo Comparator group

Description:

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

Treatment:

Device: 2D HD laparoscopy

3D HD laparoscopy

Active Comparator group

Description:

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

Treatment:

Device: 3D HD laparoscopy