Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
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|ClinicalTrials.gov Identifier: NCT00562900|
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 26, 2007
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
|Condition or disease||Intervention/treatment||Phase|
|Cholecystolithiasis||Procedure: robotic assisted cholecystectomy Procedure: Laparoscopic cholecystectomy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Robotic Assisted Versus Laparoscopic Cholecystectomy -|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||February 2007|
|Active Comparator: A, robotic||
Procedure: robotic assisted cholecystectomy
robotic assisted cholecystectomy
|Active Comparator: B, laparoscopic||
Procedure: Laparoscopic cholecystectomy
- complications [ Time Frame: Dec 04 - Feb 06 ]
- Conversion rates, operative time, hospital-costs [ Time Frame: Dec 2004 - Feb 2006 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562900
|University Hospital of Zurich|
|Principal Investigator:||stefan breitenstein, MD||UniversitaetsSpital Zuerich|