NCT00562900

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

November 7, 2007

Last Update Submit

November 23, 2007

Conditions

Cholecystolithiasis

Outcome Measures

Primary Outcomes (1)

  • complications

    Dec 04 - Feb 06

Secondary Outcomes (1)

  • Conversion rates, operative time, hospital-costs

    Dec 2004 - Feb 2006

Study Arms (2)

A, robotic

ACTIVE COMPARATOR
Procedure: robotic assisted cholecystectomy

B, laparoscopic

ACTIVE COMPARATOR
Procedure: Laparoscopic cholecystectomy

Interventions

robotic assisted cholecystectomyPROCEDURE

robotic assisted cholecystectomy

A, robotic
Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy

B, laparoscopic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cholecystectomy due to symptomatic cholecystolithiasis
  • Acute or chronic cholecystitis

You may not qualify if:

  • Patients \< 18 years
  • Primary open cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • 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. doi: 10.1097/SLA.0b013e318172501f.

    PMID: 18520226DERIVED

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • stefan breitenstein, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 26, 2007

Study Start

December 1, 2004

Study Completion

February 1, 2007

Last Updated

November 26, 2007

Record last verified: 2007-11

Locations

CH(1)