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

Cholecystolithiasis Clinical Trial

Official title:

Robotic Assisted Versus Laparoscopic Cholecystectomy -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562900
• Other study ID #: BrS_10-07
• Secondary ID: BrS_10-07
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2007
• Last updated: November 23, 2007
• Start date: December 2004
• Est. completion date: February 2007

Study information

• Verified date: November 2007
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Cholecystectomy due to symptomatic cholecystolithiasis

• Acute or chronic cholecystitis

Exclusion criteria:

• Patients < 18 years

• Primary open cholecystectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• robotic assisted cholecystectomy
robotic assisted cholecystectomy
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications		Dec 04 - Feb 06
Secondary	Conversion rates, operative time, hospital-costs		Dec 2004 - Feb 2006