Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study

Phase 4

Completed

• Conditions: Cholecystolithiasis
• Interventions: Procedure: robotic assisted cholecystectomy; Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT00562900
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2004-12
• Study Completion: 2007-02
• Status Verified: 2007-11
• Study First Submitted: 2007-11-07
• Study First Submitted QC: 2007-11-23
• Last Update Submitted: 2007-11-23
• Study First Posted: 2007-11-26
• Last Update Posted: 2007-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, robotic	robotic assisted cholecystectomy	-
B, laparoscopic	Laparoscopic cholecystectomy	-

Primary Outcome Measures

Name	Time	Method
complications	Dec 04 - Feb 06

Secondary Outcome Measures

Name	Time	Method
Conversion rates, operative time, hospital-costs	Dec 2004 - Feb 2006

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland