A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy (MC-UsD)

November 6, 2012 updated by: Kuopio University Hospital

A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.

Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

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
      • Kuopio, Finland, 70211
        • 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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud

  • ASA physical status 1-3
  • Body mass index 18-30
  • AGE 18 - 75 years

Exclusion Criteria:

  • Pregnancy or lactating
  • common bile-duct stones
  • acute cholecystitis
  • previous upper abdominal operation
  • Chirrosis
  • Renal disease
  • Pancreatitis
  • ASA 4-5
  • Participation of any other clinical trial within 30 days before the start of the screening period
  • History of uncontrolled cardiovascular, epileptic disorder, psychosis.

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
EXPERIMENTAL: Minilaparotomy cholecystectomy with ultrasonic scissors
Minilaparotomy vs laparoscopy
Procedure: Minilaparotomy vs laparoscopy
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
ACTIVE_COMPARATOR: Laparoscopic cholecystectomy
Minilaparotomy vs laparoscopy
Procedure: Minilaparotomy vs laparoscopy
MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early recovery
Time Frame: One month
Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroperative outcome
Time Frame: 24 hours
Operative time, time at the operation theatre, bleeding, length of skin incision
24 hours

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

September 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (ESTIMATE)

November 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2012

Last Update Submitted That Met QC Criteria

November 6, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5204520

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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