3D HD Versus 2D HD in Cholecystectomy

Not Applicable

• Conditions: Gall Bladder Disease; Cholelithiasis
• Interventions: Device: 3D HD laparoscopy; Device: 2D HD laparoscopy

• Registration Number: NCT02396927
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-26
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3D HD laparoscopy	3D HD laparoscopy	Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
2D HD laparoscopy	2D HD laparoscopy	Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode

Primary Outcome Measures

Name	Time	Method
Number of errors during the dissection of the Calot´s triangle	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark