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Completed

NCT Number: NCT01276886

Italian Study Group on Complicated Diverticulosis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of:

  • abdominal pain,
  • leukocytosis (>11x109)
  • fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema)

The CT criteria for the diagnosis included at least one of:

  • a localized thickening (≥4 mm) of the colonic wall
  • signs of inflammation of the pericolic fat
  • abscess
  • extraluminal air
  • extraluminal contrast

The ultrasound criteria included at least two of:

  • bowel wall thickening (>4 mm)
  • diverticular inflammation
  • pericolic fat edema
  • intramural or pericolic inflammatory mass
  • intramural fistula

Water soluble contrast enema criteria included at least two of:

  • segmental luminal narrowing
  • a tethered mucosa
  • a mass effect
  • extravasation of contrast
  • the presence of extraluminal air

Exclusion criteria

  • inflammatory bowel disease
  • irritable bowel syndrome
  • colorectal cancer
  • diseases precluding adequate follow up

Treatment and study plan

Antibiotic

Drug

Colonic resection with or without stoma

Procedure

Primary outcomes

  1. to assess the rate of recurrence of acute diverticulitis requiring hospitalization during the follow-up period

    Time frame: 10 years

Secondary outcomes

  1. to assess the risks of emergency surgery, stoma and disease-related mortality during the follow up

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per lo Studio della Diverticolite Complicata

Other

Registry information

Official study title

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

Acronym: GISDIC

Important dates

Study start
1996
Primary completion
1999
Study completion
1999
First posted
Jan 13, 2011
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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