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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01278472
First received: January 14, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 14, 2011
January 14, 2011
January 2011
June 2012   (final data collection date for primary outcome measure)
Cosmetic Score [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
  • Body Image [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    validated score. A higher score signifies a better body image.
  • Pain [ Time Frame: up to 6 weeks postoperatively ] [ Designated as safety issue: No ]
    Visual Analogue Scale
Same as current
Not Provided
Not Provided
 
Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy
Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Symptomatic Gallstone Disease
  • Device: Single Port Cholecystectomy
    Using transumbilical single port device: SILS Port
    Other Name: SILS PT5, Covidien Inc.
  • Device: 4 Port Cholecystectomy
    using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
  • Experimental: Single Port Cholecystectomy
    Laparoscopic Cholecystectomy with single port transumbilical access
    Intervention: Device: Single Port Cholecystectomy
  • Active Comparator: 4 Port Cholecystectomy
    Laparoscopic Cholecystectomy using 4 separate conventional trocars
    Intervention: Device: 4 Port Cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stefan Breitenstein, PD, MD 044 255 33 00 stefan.breitenstein@usz.ch
Contact: Daniel C Steinemann, MD 044 255 92 84 daniel.steinemann@usz.ch
Switzerland
 
NCT01278472
2010-0321/4
Yes
PD Dr. med. Stefan Breitenstein, University Hospital Zurich, Division of Visceral and Transplantation Surgery
University of Zurich
Not Provided
Principal Investigator: Stefan Breitenstein, PD, MD University of Zurich
University of Zurich
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP