Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

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Brief Title

Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

Official Title

An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy

Brief 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.
    

Detailed Description

      Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven
      superior to conventional open cholecystectomy. However, it was rapidly overshadowed by
      laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all
      gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and
      frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy
      have been hampered by surgeons´ different expertise with the two methods. These studies
      indicate that operation time is shorter and that health care cost is lower for minilaparotomy
      compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the
      present trial is to randomize eligible patients to two groups of surgeons, well trained in
      either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the
      minilaparotomy group will consider extension of the incision when necessary, and surgeons in
      the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open
      cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria
      for participants, a cost-utility approach in the analysis, and a high external validity of
      the conclusions reached.

      Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for
      gallbladder disease.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Health-related quality of life, postoperative pain, and health care costs.

Secondary Outcome

 Compliance to evidence-based recommendations for treatment of gallstone complications, postoperative complications, operation time, hospital time, and sick leave.

Condition

Biliary Tract Diseases

Intervention

Laparoscopic cholecystectomy

Study Arms / Comparison Groups

 Laparoscopic cholecystectomy
Description:  Operation by experts in laparoscopy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

355

Start Date

September 2006

Completion Date

November 2011

Primary Completion Date

April 2011

Eligibility Criteria

        Inclusion Criteria:

          1. Cholecystectomy is considered the best available treatment.

          2. The patient understands trial information and is capable of making a decision after
             having received information.

          3. The patient wants to undergo cholecystectomy and accepts participation in the trial.

        Exclusion Criteria:

          1. Age below 18 years.

          2. The patient is unable to understand trial information.

          3. Competence for both trial groups are lacking when a patient is randomized.

          4. The cholecystectomy is part of a more extensive operation (e.g.,
             pancreaticoduodenectomy).

          5. The indication of cholecystectomy is proven or suspected cancer of the gallbladder.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Markku M Haapamäki, MD, PhD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT00370344

Organization ID

GANO-05-147M


Responsible Party

Sponsor

Study Sponsor

Umeå University

Collaborators

 Norrlandstingens Regionförbund

Study Sponsor

Markku M Haapamäki, MD, PhD, Principal Investigator, Umeå University


Verification Date

April 2015