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

University of Zurich (UZH)

Status: Unknown

Conditions: Symptomatic Gallstone Disease

Treatments: Device: Single Port Cholecystectomy; Device: 4 Port Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01278472

2010-0321/4

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Single Port Cholecystectomy

Experimental group

Description:

Laparoscopic Cholecystectomy with single port transumbilical access

Treatment:

Device: Single Port Cholecystectomy

4 Port Cholecystectomy

Active Comparator group

Description:

Laparoscopic Cholecystectomy using 4 separate conventional trocars

Treatment:

Device: 4 Port Cholecystectomy