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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01986686
Other study ID # RCB1956
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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