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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Using transumbilical single port device: SILS Port
using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
University Hospital Zurich, Division of Visceral and Transplantation Surgery
Zurich, Canton of Zurich, Switzerland
RECRUITINGCosmetic Score
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
Time frame: 6 weeks postoperatively
Body Image
validated score. A higher score signifies a better body image.
Time frame: 6 weeks postoperatively
Pain
Visual Analogue Scale
Time frame: up to 6 weeks postoperatively
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