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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University of Zurich.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278472
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
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.
Information provided by:
University of Zurich
January 14, 2011
January 17, 2011
January 17, 2011
January 2011
June 2012   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • Body Image [ Time Frame: 6 weeks postoperatively ]
    validated score. A higher score signifies a better body image.
  • Pain [ Time Frame: up to 6 weeks postoperatively ]
    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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Lurje G, Raptis DA, Steinemann DC, Amygdalos I, Kambakamba P, Petrowsky H, Lesurtel M, Zehnder A, Wyss R, Clavien PA, Breitenstein S. Cosmesis and Body Image in Patients Undergoing Single-port Versus Conventional Laparoscopic Cholecystectomy: A Multicenter Double-blinded Randomized Controlled Trial (SPOCC-trial). Ann Surg. 2015 Nov;262(5):728-34; discussion 734-5. doi: 10.1097/SLA.0000000000001474.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01278472
2010-0321/4
Yes
Not Provided
Not Provided
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