Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278472
|Contact: Stefan Breitenstein, PD, MD||044 255 33 firstname.lastname@example.org|
|Contact: Daniel C Steinemann, MD||044 255 92 email@example.com|
|University Hospital Zurich, Division of Visceral and Transplantation Surgery||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Daniel C Steinemann, MD 044 255 92 84 firstname.lastname@example.org|
|Principal Investigator: Stefan Breitenstein, PD, MD|
|Sub-Investigator: Daniel C Steinemann, MD|
|Principal Investigator:||Stefan Breitenstein, PD, MD||University of Zurich|