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

N/ACompletedNCT01986686

Stony Brook University107 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Diverticulitis

Interventions

Colon resectionPROCEDURE

Elective robotic/laparoscopic/open colon resection for diverticular disease.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Stony Brook Medicine

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Primary Study Endpoint

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.

Time frame: Minimum of 1 year after enrollment

Secondary Outcomes

Measure Length of Hospital Stay for Surgery vs Non Surgery Patients

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.

Time frame: 4 years

Mortality

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

Time frame: 4 years

Readmission

Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.

Time frame: 30 days

Post Operative Complications

Data will be collected on percent and type of complications for the surgery arm.

Time frame: 30 days

Recurrence and Treatment

Data will be collected on recurrence and treatment for recurrent diverticulitis

Time frame: 2 years

Data from ClinicalTrials.gov

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