DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized,
The aim of this study was to evaluate the feasibility, safety and patient acceptance of
outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as
powerful instrument to compare quality of life and global health status after LC performed as
a day-care procedure or with an overnight stay.
Particular attention is taken to answer to the following methodological issues:
- concealed randomization,
- ITT analysis,
- number of eligible, excluded and refusing patients clearly stated.