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
  Purpose

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 Intervention
Symptomatic Gallstone Disease
Device: Single Port Cholecystectomy
Device: 4 Port Cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 110
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278472

Contacts
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

Locations
Switzerland
University Hospital Zurich, Division of Visceral and Transplantation Surgery Recruiting
Zurich, Switzerland, 8091
Contact: Daniel C Steinemann, MD    044 255 92 84    daniel.steinemann@usz.ch   
Principal Investigator: Stefan Breitenstein, PD, MD         
Sub-Investigator: Daniel C Steinemann, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Stefan Breitenstein, PD, MD University of Zurich
  More Information

Additional Information:
No publications provided

Responsible Party: PD Dr. med. Stefan Breitenstein, University Hospital Zurich, Division of Visceral and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT01278472     History of Changes
Other Study ID Numbers: 2010-0321/4
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
cholecystectomy
laparoscopic
single-port
gallstones

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014