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

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.

• Authors: Fausto Catena, Luca Ansaloni, Elisa Bianchi, Salomone Di Saverio, Federico Coccolini, Carlo Vallicelli, Daniel Lazzareschi, Massimo Sartelli, Annalisa Amaduzzi, Annalisa Amaduzz, Antonio D Pinna
• Journal: Hepato-gastroenterology (Hepatogastroenterology) Vol. 60 Issue 127 Pg. 1552-6 (Oct 2013) ISSN: 0172-6390 [Print] Greece
• PMID: 24634923 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Topics

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