Expired Study
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Stony Brook, New York 11794


Purpose:

Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.


Study summary:

This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.


Criteria:

Inclusion Criteria: - older than or equal to 18 - history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol - the diagnosis confirmed by colonoscopy - Signed informed consent Exclusion Criteria: - Prior episode of diverticulitis - Right sided diverticulitis - Failure of recovery from first episode, defined as recurrence within one month. - Cancer found at the site on screening colonoscopy - Comorbidities prohibiting surgery (as measured by colorectal POSSUM score) - Immunosuppressed patients - Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm) - Patients who are unable to sign the informed consent


NCT ID:

NCT01986686


Primary Contact:

Principal Investigator
Roberto C Bergamaschi, MD, PhD
Stonybrook University


Backup Contact:

N/A


Location Contact:

Stony Brook, New York 11794
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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