Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis

Stony Brook University

Status: Completed

Conditions: Diverticulitis

Treatments: Procedure: Colon resection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01986686

RCB1956

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

107 participants in 2 patient groups

Observational

No Intervention group

Description:

The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

Surgery

Active Comparator group

Description:

The surgery group will be offered colon resection.

Treatment:

Procedure: Colon resection