Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

December 10, 2014 updated by: Anne Mattila, Central Finland Hospital District

Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After initiation of general anesthesia patients are randomized either to conventional or ultrasonic dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Study Type

Interventional

Enrollment (Actual)

169

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
      • Jyvaskyla, Finland, 40620
        • Jyväskylä Central 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:

  • ASA I-II
  • BMI under 35
  • normal liver enzymes
  • no bile duct dilatation in ultrasound
  • cholecystolithiasis

Exclusion Criteria:

  • NSAID allergy
  • previous upper gi-surgery
  • common bile duct stones in preoperative imaging
  • history of severe acute pancreatitis

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional diathermy hook
Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
laparoscopic cholecystectomy with ultrasonic scissors starting from fundus
Active Comparator: ultrasonic dissection
Laparoscopic cholecystectomy made with ultrasonic dissection starting from gallbladder fundus
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
Procedure: dissection of gallbladder in laparoscopic cholecystectomy
laparoscopic cholecystectomy with ultrasonic scissors starting from fundus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: 30 days
30 days
same day discharge
Time Frame: 30 days
30 days
intraoperative complications
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
morbidity
Time Frame: 30 days
30 days
readmission
Time Frame: 30 days
30 days
analgetic use
Time Frame: 30 days
30 days
postoperative nausea and vomiting
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Central Finland Hospital District

Investigators

  • Study Director: Ilmo Kellokumpu, Docent, Jyväskylä Central Hospital
  • Principal Investigator: Anne K Mattila, MD, Jyväskylä Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 10, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSSHPB10208

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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