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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:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00562900
First received: November 7, 2007
Last updated: November 23, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robotic Assisted Versus Laparoscopic Cholecystectomy -

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Zurich

Additional 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, BrS_10-07
Study First Received: November 7, 2007
Last Updated: November 23, 2007
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 20, 2014