Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Herlev Hospital
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Number of errors during the dissection of the Calot´s triangle
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients scheduled for elective cholecystectomy (out-patient treatment)
Exclusion Criteria
- •Previous upper abdominal surgery
- •ASA-score 3 or above
Outcomes
Primary Outcomes
Number of errors during the dissection of the Calot´s triangle
Time Frame: 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 Outcomes
- 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)
- Subjective assessment (Assessment of fatigue and perceived exertion)(an expected average of 15 minutes before and after the operation)
- Subjective assessment (optical modality and mental load assessment)(an expected average of 15 minutes after the operation)
Investigators
Charlotte Fergo
Miss
Herlev Hospital