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
  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:

  1. dissection starting at the triangle of Calots with electrocautery.
  2. dissection by fundus first technique with electrocautery.
  3. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 16, 2014