Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique
May 29, 2008 updated by: Sundsvall Hospital
Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection
Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.
Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients at the participating hospitals are randomized to:
- dissection starting at the triangle of Calots with electrocautery.
- dissection by fundus first technique with electrocautery.
- dissection by fundus first technique with ultrasonic dissection.
Study Type
Interventional
Enrollment (Actual)
233
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
-
-
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Sundsvall, Sweden, se-85641
- Sundsvall Hospital
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-
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:
- laparoscopic cholecystectomy
Exclusion Criteria:
- age >Z65
- ASA >3
- obesity
- previous extensive gastrointestinal surgery
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Dissection staring at the triangle of calots.
Dissection with electrocautery.
|
Randomized to three arm.
Other Names:
|
|
Active Comparator: 2
Dissection as fundus first with electrocautery.
|
Randomized to three arm.
Other Names:
|
|
Active Comparator: 3
Dissection as fundus first with ultrasonic dissection.
|
Randomized to three arm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
surgical complications
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Leif A Israelsson, MD,PhD, Umeå University
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.
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
May 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
May 26, 2008
First Submitted That Met QC Criteria
May 29, 2008
First Posted (Estimate)
June 3, 2008
Study Record Updates
Last Update Posted (Estimate)
June 3, 2008
Last Update Submitted That Met QC Criteria
May 29, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YC11
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.