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

Not Applicable

• Conditions: Symptomatic Gallstone Disease
• Interventions: Device: Single Port Cholecystectomy; Device: 4 Port Cholecystectomy

• Registration Number: NCT01278472
• Lead Sponsor: University of Zurich

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 available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Port Cholecystectomy	Single Port Cholecystectomy	Laparoscopic Cholecystectomy with single port transumbilical access
4 Port Cholecystectomy	4 Port Cholecystectomy	Laparoscopic Cholecystectomy using 4 separate conventional trocars

Primary Outcome Measures

Name	Time	Method
Cosmetic Score	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

Secondary Outcome Measures

Name	Time	Method
Body Image	6 weeks postoperatively	validated score. A higher score signifies a better body image.
Pain	up to 6 weeks postoperatively	Visual Analogue Scale

Trial Locations

Locations (1)

University Hospital Zurich, Division of Visceral and Transplantation Surgery; 🇨🇭 Zurich, Switzerland