Clinical Trial: Hospitalization or Ambulatory Treatment of Acute Diverticulitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment

Brief Summary: The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.

Detailed Summary:
Sponsor: Hospital Universitari de Bellvitge

Current Primary Outcome: Treatment failure [ Time Frame: 30 days ]

Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.


Original Primary Outcome: Same as current

Current Secondary Outcome: Recurrence, quality of life, costs [ Time Frame: 30 days ]

Recurrence of diverticulitis within 30 days; quality of life and patient satisfaction is asessed comparing management with and without admittance to the hospital and costs are calculated for the treatment in both regimens.


Original Secondary Outcome: Same as current

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: March 4, 2010
Date Started: September 2009
Date Completion:
Last Updated: June 10, 2012
Last Verified: June 2012