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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment