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Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

NCT00370344 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2015-04-24

No results posted yet for this study

Summary

The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.

Conditions

  • Biliary Tract Diseases
  • Gallbladder Diseases
  • Cholecystitis
  • Cholecystolithiasis

Interventions

PROCEDURE

Laparoscopic cholecystectomy

Operation by experts in laparoscopy. The operation may be performed as laparoscopic or converted to an open operation.

PROCEDURE

Small-incision open cholecystectomy

Operation by experts in small-incision open cholecystectomy.

Sponsors & Collaborators

  • Norrlandstingens Regionförbund

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Markku M Haapamäki, MD, PhD · Umeå University

  • Mats Rosenmüller, MD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2011-04-30
Completion
2011-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370344 on ClinicalTrials.gov