Symptomatic Gallstone Disease Clinical Trial
Official title:
Cosmesis and Body Image After Single Port Laparoscopic or Conventional Laparoscopic Cholecystectomy: A Double Blinded Randomised Controlled Trial
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.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | December 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Division of Visceral and Transplantation Surgery | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cosmetic 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 | 6 weeks postoperatively | No |
| Secondary | Body Image | validated score. A higher score signifies a better body image. | 6 weeks postoperatively | No |
| Secondary | Pain | Visual Analogue Scale | up to 6 weeks postoperatively | No |