The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) Study: multicenter randomized, double-blind, controlled trial of laparoscopic versus open surgery for acute cholecystitis.

BACKGROUND/AIMS: In some randomized controlled trials laparoscopic cholecystectomy (LC) for acute cholecystitis was associated with a shorter hospital stay when compared with open cholecystectomy (OC). These studies were not double blinded and without intention to treat purpose.

METHODOLOGY: The present study project was a prospective, randomized investigation. The study was performed in the Department of General, Emergency and Transplant Surgery St Orsola-Malpighi University Hospital (Bologna, Italy). Subjects were divided in two groups: in the first group the patient was submitted to LC while in the second group was submitted to OC.

RESULTS

Of 164 consecutive patients, 20 were excluded from the study. The two groups were similar in demographic and clinical characteristics. Seven (9.7%) patients in the LC group required conversion to OC. There were no deaths or bile duct lesions in either group, and the postoperative complication rate was similar (p=n.s.). The mean postoperative hospital stay was also comparable.

CONCLUSIONS

Even though LC for acute and gangrenous cholecystitis is technically demanding, in experienced hands it is safe and effective. It does not increase the mortality and the morbidity rate with a low conversion rate and no difference in hospital stay.