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

Hepatogastroenterology. 2013 Oct;60(127):1552-6.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Chi-Square Distribution
  • Cholecystectomy / adverse effects
  • Cholecystectomy / methods*
  • Cholecystectomy, Laparoscopic* / adverse effects
  • Cholecystitis, Acute / diagnosis
  • Cholecystitis, Acute / surgery*
  • Clinical Competence
  • Female
  • Humans
  • Italy
  • Length of Stay
  • Male
  • Postoperative Complications / etiology
  • Prospective Studies
  • Recovery of Function
  • Time Factors
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN27929536