Clinical trial NCT01986686: Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
Official title: Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticulitis
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-11-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Primary Study Endpoint
timeFrame: Minimum of 1 year after enrollment
Secondary outcomes:
measure: Measure Length of Hospital Stay for Surgery vs Non Surgery Patients
timeFrame: 4 years
measure: Mortality
timeFrame: 4 years
measure: Readmission
timeFrame: 30 days
measure: Post Operative Complications
timeFrame: 30 days
measure: Recurrence and Treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
Study officials:
affiliation: Stonybrook University
name: Roberto C Bergamaschi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: You K, Bendl R, Taut C, Sullivan R, Gachabayov M, Bergamaschi R; Study Group on Diverticulitis. Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively. Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23.