Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
- Conditions
- Diverticulitis
- Interventions
- Procedure: Colon resection
- Registration Number
- NCT01986686
- Lead Sponsor
- Stony Brook University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Surgery Colon resection The surgery group will be offered colon resection.
- Primary Outcome Measures
Name Time Method Primary Study Endpoint Minimum of 1 year after enrollment The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
- Secondary Outcome Measures
Name Time Method Post Operative Complications 30 days Data will be collected on percent and type of complications for the surgery arm.
Measure Length of Hospital Stay for Surgery vs Non Surgery Patients 4 years Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.
Recurrence and Treatment 2 years Data will be collected on recurrence and treatment for recurrent diverticulitis
Mortality 4 years Data will be collected on percent of patients who die during the follow-up period after enrollment.
Readmission 30 days Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.
Trial Locations
- Locations (1)
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States