Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized Controlled Trial. (DOLCE)

NCT01052727 PHASE4 UNKNOWN

DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized, controlled trial. 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.

Details

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	PHASE4
Status	UNKNOWN
Enrolment	100

Conditions

• Cholelithiasis

Interventions

• Laparoscopic Cholecystectomy

Countries

Italy