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

Sponsor
Sundsvall Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00689663
Collaborator
(none)
233
Enrollment
1
Location
3
Arms
19
Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic cholecystectomy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
233 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Dissection staring at the triangle of calots. Dissection with electrocautery.

Procedure: Laparoscopic cholecystectomy
Randomized to three arm.
Other Names:
  • Randomised study.

    		•
    Active Comparator: 2

    Dissection as fundus first with electrocautery.

    Procedure: Laparoscopic cholecystectomy
    Randomized to three arm.
    Other Names:
  • Randomised study.

    		•
    Active Comparator: 3

    Dissection as fundus first with ultrasonic dissection.

    Procedure: Laparoscopic cholecystectomy
    Randomized to three arm.
    Other Names:
  • Randomised study.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate [30 days]

    Secondary Outcome Measures

    1. surgical complications [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • laparoscopic cholecystectomy
    Exclusion Criteria:

    • age >Z65

    • ASA >3

    • obesity

    • previous extensive gastrointestinal surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sundsvall Hospital Sundsvall Sweden se-85641

    Sponsors and Collaborators

    • Sundsvall Hospital

    Investigators

    • Study Chair: Leif A Israelsson, MD,PhD, Umea University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00689663
    Other Study ID Numbers:
    • YC11
    First Posted:
    Jun 3, 2008
    Last Update Posted:
    Jun 3, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    cholecystectomy

    Study Results

    No Results Posted as of Jun 3, 2008