Symptomatic Gallstone Disease
Conditions
Keywords
cholecystectomy, laparoscopic, single-port, gallstones
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.
Interventions
DEVICESingle Port Cholecystectomy
Using transumbilical single port device: SILS Port
DEVICE4 Port Cholecystectomy
using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body Image | 6 weeks postoperatively | validated score. A higher score signifies a better body image. |
| Pain | up to 6 weeks postoperatively | Visual Analogue Scale |
Countries
Switzerland
Contacts
Primary ContactStefan Breitenstein, PD, MD
Backup ContactDaniel C Steinemann, MD
Outcome results
None listed