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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562900
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 26, 2007
Information provided by:
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

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Procedure: robotic assisted cholecystectomy Procedure: Laparoscopic cholecystectomy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Assisted Versus Laparoscopic Cholecystectomy -
Study Start Date : December 2004
Actual Study Completion Date : February 2007

Arm Intervention/treatment
Active Comparator: A, robotic Procedure: robotic assisted cholecystectomy
robotic assisted cholecystectomy

Active Comparator: B, laparoscopic Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

Primary Outcome Measures :
  1. complications [ Time Frame: Dec 04 - Feb 06 ]

Secondary Outcome Measures :
  1. Conversion rates, operative time, hospital-costs [ Time Frame: Dec 2004 - Feb 2006 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Cholecystectomy due to symptomatic cholecystolithiasis
  • Acute or chronic cholecystitis

Exclusion criteria:

  • Patients < 18 years
  • Primary open cholecystectomy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00562900

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University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Principal Investigator: stefan breitenstein, MD UniversitaetsSpital Zuerich

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00562900     History of Changes
Other Study ID Numbers: BrS_10-07
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: November 26, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical