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

Tracking Information

First Received Date ^ICMJE

January 14, 2011

Last Updated Date

January 14, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Symptomatic Gallstone Disease

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

December 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients above 18 years of age for elective cholecystectomy
Written informed consent from the subject
INR < 1.4, platelet count > 50'000/mcl

Exclusion Criteria:

Women in pregnancy
Contraindications on ethical grounds
Severe coagulopathy (platelet < 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR > 1.4
liver cirrhosis
Enrolment of the investigator, his/her family members, employees and other dependent persons

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01278472

Other Study ID Numbers ^ICMJE

2010-0321/4

Has Data Monitoring Committee

Yes

Responsible Party

PD Dr. med. Stefan Breitenstein, University Hospital Zurich, Division of Visceral and Transplantation Surgery

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefan Breitenstein, PD, MD

University of Zurich

Information Provided By

University of Zurich

Verification Date

January 2011

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

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