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 recurrence of chronic symptoms attributable to complicated
diverticular disease, new episodes of AD, new hospital admissions for AD, type of treatment
and outcome.
Recurrence was defined as a new episode of AD requiring hospitalization that occurred at
least 2 months after complete resolution of the index episode which resulted in inclusion in
the study. If surgery was performed, the timing, type of procedure, Hinchey stage and
complications were recorded.
Data collection A standardized flow sheet was used to collect data on medical history,
diagnostic work up, type of treatment and follow up to create a dedicated database. Gender,
age, date of hospital admission and discharge, diagnosis on admission and discharge,
co-morbidities (diabetes mellitus, cardiovascular disease, atherosclerosis, liver or renal
failure), symptoms experienced before admission and their duration, history of
diverticulosis, previous episodes of AD, laboratory tests, and treatment performed were
recorded. Where surgery was performed, the date and type of procedure, the operative findings
including Hinchey's classification (16) and details of the operation (incision, extension of
resection, type of anastomosis, covering stoma, drains), pathology report, and postoperative
complications occurring within 30 days, were all recorded.
End points The primary endpoint was to assess the rate of recurrence of AD requiring
hospitalization during the follow-up period. Additional endpoints were to assess the risks of
emergency surgery, stoma and disease-related mortality during the follow up.
Details
Lead Sponsor:
Gruppo Italiano per lo Studio della Diverticolite Complicata