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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278472
Recruitment Status : Unknown
Verified January 2011 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : January 17, 2011
Last Update Posted : January 17, 2011
Information provided by:
University of Zurich

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
Symptomatic Gallstone Disease Device: Single Port Cholecystectomy Device: 4 Port Cholecystectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

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 Name: 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

Primary Outcome Measures :
  1. Cosmetic Score [ Time Frame: 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 [ Time Frame: 6 weeks postoperatively ]
    validated score. A higher score signifies a better body image.

  2. Pain [ Time Frame: up to 6 weeks postoperatively ]
    Visual Analogue Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278472

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Contact: Stefan Breitenstein, PD, MD 044 255 33 00
Contact: Daniel C Steinemann, MD 044 255 92 84

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University Hospital Zurich, Division of Visceral and Transplantation Surgery Recruiting
Zurich, Switzerland, 8091
Contact: Daniel C Steinemann, MD    044 255 92 84   
Principal Investigator: Stefan Breitenstein, PD, MD         
Sub-Investigator: Daniel C Steinemann, MD         
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Stefan Breitenstein, PD, MD University of Zurich
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PD Dr. med. Stefan Breitenstein, University Hospital Zurich, Division of Visceral and Transplantation Surgery Identifier: NCT01278472    
Other Study ID Numbers: 2010-0321/4
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011
Keywords provided by University of Zurich:
Additional relevant MeSH terms:
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Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical