Cholelithiasis, Gall Bladder Disease
Conditions
Keywords
3D, Three-dimensional, laparoscopy, cholecystectomy
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.
Interventions
DEVICE3D HD laparoscopy
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
DEVICE2D HD laparoscopy
Placebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for elective cholecystectomy (out-patient treatment)
Exclusion criteria
* Previous upper abdominal surgery * ASA-score 3 or above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Duration of the dissection of the Calot´s triangle | Expected duration: 20 minutes | — |
| 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. |
| 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. |
Countries
Denmark
Contacts
Primary ContactCharlotte Fergo
Outcome results
None listed