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

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00562900

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Robotic Assisted Versus Laparoscopic Cholecystectomy -

Resource links provided by NLM:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

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
A, robotic: Active Comparator	Procedure: robotic assisted cholecystectomy robotic assisted cholecystectomy
B, laparoscopic: Active Comparator	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

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	BrS_10-07, BrS_10-07
Study First Received:	November 7, 2007
Last Updated:	November 23, 2007
ClinicalTrials.gov Identifier:	NCT00562900 History of Changes
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

ClinicalTrials.gov processed this record on September 10, 2009