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

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00562900
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Dec 1, 2004
• Actual Study Completion Date: Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A, robotic	Procedure: robotic assisted cholecystectomy; robotic assisted cholecystectomy
Active Comparator: B, laparoscopic	Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

1. complications [Dec 04 - Feb 06]

Secondary Outcome Measures

1. Conversion rates, operative time, hospital-costs [Dec 2004 - Feb 2006]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Zurich	Zurich		Switzerland

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: stefan breitenstein, MD, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00562900
• Other Study ID Numbers: BrS_10-07; BrS_10-07
• First Posted: Nov 26, 2007
• Last Update Posted: Nov 26, 2007
• Last Verified: Nov 1, 2007

• Additional relevant MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones

Study Results

No Results Posted as of Nov 26, 2007