MedPath

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

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
SurgeryColon resectionThe surgery group will be offered colon resection.
Primary Outcome Measures
NameTimeMethod
Primary Study EndpointMinimum 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
NameTimeMethod
Post Operative Complications30 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 Patients4 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 Treatment2 years

Data will be collected on recurrence and treatment for recurrent diverticulitis

Mortality4 years

Data will be collected on percent of patients who die during the follow-up period after enrollment.

Readmission30 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

© Copyright 2025. All Rights Reserved by MedPath