Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
NCT ID: NCT00562900
Last Updated: 2007-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2004-12-31
2007-02-28
Brief Summary
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* Trial with surgical intervention
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A, robotic
robotic assisted cholecystectomy
robotic assisted cholecystectomy
B, laparoscopic
Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Interventions
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robotic assisted cholecystectomy
robotic assisted cholecystectomy
Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Eligibility Criteria
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Inclusion Criteria
* Acute or chronic cholecystitis
Exclusion Criteria
* Primary open cholecystectomy
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Principal Investigators
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stefan breitenstein, MD
Role: PRINCIPAL_INVESTIGATOR
UniversitaetsSpital Zuerich
Locations
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University Hospital of Zurich
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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BrS_10-07
Identifier Type: -
Identifier Source: secondary_id
BrS_10-07
Identifier Type: -
Identifier Source: org_study_id