Cholecystolithiasis
Conditions
Brief summary
Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience. * Trial with surgical intervention
Detailed description
Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery. The study is designed to assess the potential benefits of robotic-assisted cholecystectomy. To achieve a high level of evidence we chose a prospective case matched controlled methodology. Three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. Each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy. The robotic assisted operations are performed with the 3- arm Da Vinci robot system (Da Vinci Robot, Intuitive Surgical). Similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.
Interventions
robotic assisted cholecystectomy
Laparoscopic cholecystectomy
Sponsors
Study design
Eligibility
Inclusion criteria
* Cholecystectomy due to symptomatic cholecystolithiasis * Acute or chronic cholecystitis
Exclusion criteria
* Patients \< 18 years * Primary open cholecystectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complications | Dec 04 - Feb 06 |
Secondary
| Measure | Time frame |
|---|---|
| Conversion rates, operative time, hospital-costs | Dec 2004 - Feb 2006 |
Countries
Switzerland