3D HD Versus 2D HD in Cholecystectomy

Study Overview
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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.

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

Conditions
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Cholelithiasis, Gall Bladder Disease

Intervention / Treatment
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* Device: 3D HD laparoscopy
* Device: 2D HD laparoscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2D HD laparoscopy<br>Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode | Device: 2D HD laparoscopy<br>* Placebo<br>|
| Active Comparator: 3D HD laparoscopy<br>Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode | Device: 3D HD laparoscopy<br>* Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.<br>* Other names: Olympus 3D ENDOEYE FLEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Expected duration: 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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) | The surgeon will fill out questionnaires and scales. | an expected average of 15 minutes after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, Three-dimensional, laparoscopy, cholecystectomy