Clinical Trial: Italian Study Group on Complicated Diverticulosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Italian Study Group on Complicated Diverticulosis: The Natural History of Left-sided Acute Diverticulitis

Brief Summary:

Patients were recruited over a four year period from 1996 to 1999. Those admitted in the years 1996 and 1997 were retrospectively accrued from the clinical records, while patients treated between 1998 and 1999 patients were entered on the database prospectively on admission.

Inclusion criteria All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain, associated with leukocytosis (>11x109) and/or fever >38°C, confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) either alone or in combination and/or by operative findings, entered the study. The CT criteria for the diagnosis included a localized thickening (≥4 mm) of the colonic wall and signs of inflammation of the pericolic fat, with abscess and/or extraluminal air and/or extraluminal contrast. The criteria for ultrasound included at least two of the following signs: bowel wall thickening (>4 mm), diverticular inflammation, pericolic fat edema, intramural or pericolic inflammatory mass, intramural fistula. The diagnostic criteria for water soluble contrast enema included segmental luminal narrowing and a tethered mucosa with or without a mass effect or extravasation of contrast and/or the presence of extraluminal air.

Exclusion criteria Patients with inflammatory bowel disease, irritable bowel syndrome, colorectal cancer or diseases precluding adequate follow up, were excluded from the study.

Treatment Patients were treated conservatively (antibiotics, I.V. nutrition, CT/US guided abscess drainage) or surgically according to the local policy of each center.

Follow up Follow up was carried out according to local policy. The following data were collected: persistence or recu

Detailed Summary:
Sponsor: Gruppo Italiano per lo Studio della Diverticolite Complicata

Current Primary Outcome: to assess the rate of recurrence of acute diverticulitis requiring hospitalization during the follow-up period [ Time Frame: 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up [ Time Frame: 10 years ]

Original Secondary Outcome: Same as current

Information By: Gruppo Italiano per lo Studio della Diverticolite Complicata

Dates:
Date Received: January 12, 2011
Date Started: January 1996
Date Completion:
Last Updated: January 21, 2011
Last Verified: December 2010