Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
Primary Purpose
Cholecystolithiasis
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
robotic assisted cholecystectomy
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystolithiasis
Eligibility Criteria
Inclusion criteria:
- Cholecystectomy due to symptomatic cholecystolithiasis
- Acute or chronic cholecystitis
Exclusion criteria:
- Patients < 18 years
- Primary open cholecystectomy
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A, robotic
B, laparoscopic
Arm Description
Outcomes
Primary Outcome Measures
complications
Secondary Outcome Measures
Conversion rates, operative time, hospital-costs
Full Information
NCT ID
NCT00562900
First Posted
November 7, 2007
Last Updated
November 23, 2007
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00562900
Brief Title
Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
Official Title
Robotic Assisted Versus Laparoscopic Cholecystectomy -
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, robotic
Arm Type
Active Comparator
Arm Title
B, laparoscopic
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
robotic assisted cholecystectomy
Intervention Description
robotic assisted cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
complications
Time Frame
Dec 04 - Feb 06
Secondary Outcome Measure Information:
Title
Conversion rates, operative time, hospital-costs
Time Frame
Dec 2004 - Feb 2006
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Cholecystectomy due to symptomatic cholecystolithiasis
Acute or chronic cholecystitis
Exclusion criteria:
Patients < 18 years
Primary open cholecystectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefan breitenstein, MD
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18520226
Citation
Breitenstein S, Nocito A, Puhan M, Held U, Weber M, Clavien PA. Robotic-assisted versus laparoscopic cholecystectomy: outcome and cost analyses of a case-matched control study. Ann Surg. 2008 Jun;247(6):987-93. doi: 10.1097/SLA.0b013e318172501f.
Results Reference
derived
Learn more about this trial
Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
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