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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Cholecystolithiasis

Treatments: Procedure: Laparoscopic cholecystectomy; Procedure: robotic assisted cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00562900

BrS_10-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cholecystectomy due to symptomatic cholecystolithiasis
• Acute or chronic cholecystitis

Exclusion criteria

• Patients < 18 years
• Primary open cholecystectomy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A, robotic

Active Comparator group

Treatment:

Procedure: robotic assisted cholecystectomy

B, laparoscopic

Active Comparator group

Treatment:

Procedure: Laparoscopic cholecystectomy