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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562900
First Posted: November 26, 2007
Last Update Posted: November 26, 2007
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.
Information provided by:
University of Zurich
  Purpose

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 Intervention Phase
Cholecystolithiasis Procedure: robotic assisted cholecystectomy Procedure: Laparoscopic cholecystectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Assisted Versus Laparoscopic Cholecystectomy -

Further study details as provided by University of Zurich:

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

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

Enrollment: 50
Study Start Date: December 2004
Study Completion Date: February 2007
Arms Assigned Interventions
Active Comparator: A, robotic Procedure: robotic assisted cholecystectomy
robotic assisted cholecystectomy
Active Comparator: B, laparoscopic Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion criteria:

  • Cholecystectomy due to symptomatic cholecystolithiasis
  • Acute or chronic cholecystitis

Exclusion criteria:

  • Patients < 18 years
  • Primary open cholecystectomy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00562900


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00562900     History of Changes
Other Study ID Numbers: BrS_10-07
First Submitted: November 7, 2007
First Posted: November 26, 2007
Last Update Posted: November 26, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical