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Completed

NCT Number: NCT00562900

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Zurich

Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cholecystectomy due to symptomatic cholecystolithiasis
  • Acute or chronic cholecystitis

Exclusion criteria

  • Patients < 18 years
  • Primary open cholecystectomy

Treatment and study plan

robotic assisted cholecystectomy

Procedure

robotic assisted cholecystectomy

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy

Primary outcomes

  1. complications

    Time frame: Dec 04 - Feb 06

Secondary outcomes

  1. Conversion rates, operative time, hospital-costs

    Time frame: Dec 2004 - Feb 2006

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Robotic Assisted Versus Laparoscopic Cholecystectomy -

Important dates

Study start
2004
Study completion
2007
First posted
Nov 26, 2007
Registry last updated
Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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