Clincosm LogoSign in Get a demo

Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy

Sponsor
University of Zurich (Other)
Overall Status
Unknown status
CT.gov ID
NCT01278472
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
23
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery.

The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency.

Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints.

This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.

Condition or Disease Intervention/Treatment Phase
  • Device: Single Port Cholecystectomy
  • Device: 4 Port Cholecystectomy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Port Cholecystectomy

Laparoscopic Cholecystectomy with single port transumbilical access

Device: Single Port Cholecystectomy
Using transumbilical single port device: SILS Port
Other Names:
  • SILS PT5, Covidien Inc.

    		•
    Active Comparator: 4 Port Cholecystectomy

    Laparoscopic Cholecystectomy using 4 separate conventional trocars

    Device: 4 Port Cholecystectomy
    using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports

    Outcome Measures

    Primary Outcome Measures

    1. Cosmetic Score [6 weeks postoperatively]

      validated score where the minimum is 3 and the maximum 24 points. A higher score signifies a greater satisfaction of the physical appearance of the scar

    Secondary Outcome Measures

    1. Body Image [6 weeks postoperatively]

      validated score. A higher score signifies a better body image.

    2. Pain [up to 6 weeks postoperatively]

      Visual Analogue Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients above 18 years of age for elective cholecystectomy

    2. Written informed consent from the subject

    3. INR < 1.4, platelet count > 50'000/mcl

    Exclusion Criteria:

    1. Women in pregnancy

    2. Contraindications on ethical grounds

    3. Severe coagulopathy (platelet < 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR > 1.4

    4. liver cirrhosis

    5. Enrolment of the investigator, his/her family members, employees and other dependent persons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Zurich, Division of Visceral and Transplantation Surgery Zurich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Principal Investigator: Stefan Breitenstein, PD, MD, University of Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01278472
    Other Study ID Numbers:
    • 2010-0321/4
    First Posted:
    Jan 17, 2011
    Last Update Posted:
    Jan 17, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    cholecystectomy
    laparoscopic
    single-port
    gallstones
    Additional relevant MeSH terms:
    Gallstones
    Cholelithiasis
    Cholecystolithiasis

    Study Results

    No Results Posted as of Jan 17, 2011