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

Diverticulitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986686
• Other study ID #: RCB1956
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: May 26, 2017
• Start date: October 2011
• Est. completion date: July 16, 2016

Study information

• Verified date: May 2017
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 16, 2016
• Est. primary completion date: July 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Procedure:
• Colon resection
Elective robotic/laparoscopic/open colon resection for diverticular disease.

Locations

Country	Name	City	State
United States	Stony Brook Medicine	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

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