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

Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis
• Intervention / Treatment: Procedure: Colon resection

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational; The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
Active Comparator: Surgery; The surgery group will be offered colon resection.	Procedure: Colon resection; Elective robotic/laparoscopic/open colon resection for diverticular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Minimum of 1 year after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years
Mortality	Data will be collected on percent of patients who die during the follow-up period after enrollment.	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.	30 days
Post Operative Complications	Data will be collected on percent and type of complications for the surgery arm.	30 days
Recurrence and Treatment	Data will be collected on recurrence and treatment for recurrent diverticulitis	2 years

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 16, 2016
• Study Completion (Actual): July 16, 2016

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimate): November 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: RCB1956