Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

June 7, 2013 updated by: Matti Eskelinen, Kuopio University Hospital
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cholelithiasis confirmed by preoperative ulrasound
  • No significant co-morbidities
  • The ASA physical status classification 1 or 2
  • Age 18 to 65 yrs.
  • BMI less than 35
  • Less than a one hour journey from hospital to home
  • Patient´s own motivation to daysurgery

Exclusion Criteria:

  • Elevated liver laboratory tests
  • Earlier jaundice
  • A suspicion or verified stones in the common bile duct
  • Acute cholecystitis
  • A history of pancreatitis
  • Hepatic cirrhosis
  • Suspicion of cancer
  • Previous open upper abdominal surgery
  • Asthma
  • Peptic ulcer
  • Bleeding disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Minilaparotomy
Minilaparotomy cholecystectomy as a day surgery
Procedure: Cholecystectomy
OTHER: Laparoscopy
Laparoscopic cholecystectomy as a day surgery
Procedure: Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chronic post-surgical pain
Time Frame: Five year outcome
Five year outcome

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Five year outcome
Five year outcome

Other Outcome Measures

Outcome Measure
Time Frame
Cosmetic satisfaction
Time Frame: Five year outcome
Five year outcome
Residual abdominal symptoms
Time Frame: Five year outcome
Five year outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (ESTIMATE)

June 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5200630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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