Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique

This study has been completed.

Sponsor:

Information provided by:

Sundsvall Hospital

ClinicalTrials.gov Identifier:

NCT00689663

First received: May 26, 2008

Last updated: May 29, 2008

Last verified: May 2008

History of Changes

Purpose

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.

Condition	Intervention
Cholecystectomy	Procedure: Laparoscopic cholecystectomy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection

Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:

Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

surgical complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	233
Study Start Date:	May 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Dissection staring at the triangle of calots. Dissection with electrocautery.	Procedure: Laparoscopic cholecystectomy Randomized to three arm. Other Name: Randomised study.
Active Comparator: 2 Dissection as fundus first with electrocautery.	Procedure: Laparoscopic cholecystectomy Randomized to three arm. Other Name: Randomised study.
Active Comparator: 3 Dissection as fundus first with ultrasonic dissection.	Procedure: Laparoscopic cholecystectomy Randomized to three arm. Other Name: Randomised study.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

laparoscopic cholecystectomy

Exclusion Criteria:

age >Z65
ASA >3
obesity
previous extensive gastrointestinal surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689663

Locations

Sweden
Sundsvall Hospital
Sundsvall, Sweden, se-85641

Sponsors and Collaborators

Sundsvall Hospital

Investigators

Study Chair:

Leif A Israelsson, MD,PhD

Umea University

More Information

Publications:

Cengiz Y, Jänes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3.

Responsible Party:	Divisionschef Margaretha Röden, Landstinget Västernorrland
ClinicalTrials.gov Identifier:	NCT00689663 History of Changes
Other Study ID Numbers:	YC11
Study First Received:	May 26, 2008
Last Updated:	May 29, 2008
Health Authority:	Sweden: The National Board of Health and Welfare

Keywords provided by Sundsvall Hospital:

cholecystectomy

ClinicalTrials.gov processed this record on May 16, 2013

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