Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Diverticulitis |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 10/20/2017 |
| Start Date: | October 2011 |
| End Date: | July 16, 2016 |
Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
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.
management of a first episode of Hinchey II diverticulitis. Information will be collected on
recurrence rates and major complications in both groups.
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.
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.
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
We found this trial at
1
site
Stony Brook, New York 11794
Principal Investigator: Roberto C Bergamaschi, MD, PhD
Phone: 631-444-3036
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