Cholecystolithiasis
Conditions
Keywords
3D, laparoscopy, cholecystectomy
Brief summary
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
Interventions
PROCEDURE2D laparoscopic cholecystectomy
PROCEDURE3D laparoscopic cholecystectomy
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for laparoscopic cholecystectomy
Exclusion criteria
* Some other surgical operation planned during LCC * Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis) * Operating surgeon experience less than 5 3D laparoscopy operations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of surgery | Expected average time of surgery 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for conversion into open surgery | During the operation, expected average time of surgery 1 hour | — |
| Intraoperative complications | During the operation, expected average time of surgery 1 hour | Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture |
| Complications, Clavien-Dindo classification | 30 days after randomization | — |
| Postoperative stay in hospital | Expected range 0-7 day | — |
| Bleeding | During the operation, expected average time of surgery 1 hour | — |
| Total need of opioids in milligrams | Expected range 0-7 day | — |
| Mortality | 30 days after randomization | — |
| Operation theatre time | Expected average 1,5 hours | — |
| Postoperative pain, VAS | Expected range 0-7 day | — |
| Number of participants with readmission(s) | 30 days after randomization | — |
Other
| Measure | Time frame |
|---|---|
| Incisional hernias | after 1, 5 and 10 year |
Countries
Finland
Outcome results
None listed