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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01986686
First Posted: November 18, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stony Brook University
  Purpose
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.

Condition Intervention
Diverticulitis Procedure: Colon resection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Primary Study Endpoint [ Time Frame: Minimum 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:
  • Measure Length of Hospital Stay for Surgery vs Non Surgery Patients [ Time Frame: 4 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.

  • Mortality [ Time Frame: 4 years ]
    Data will be collected on percent of patients who die during the follow-up period after enrollment.

  • Readmission [ Time Frame: 30 days ]
    Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.

  • Post Operative Complications [ Time Frame: 30 days ]
    Data will be collected on percent and type of complications for the surgery arm.

  • Recurrence and Treatment [ Time Frame: 2 years ]
    Data will be collected on recurrence and treatment for recurrent diverticulitis


Enrollment: 107
Study Start Date: October 2011
Study Completion Date: July 16, 2016
Primary Completion Date: July 16, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986686


Locations
United States, New York
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Roberto C Bergamaschi, MD, PhD Stonybrook University
  More Information

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01986686     History of Changes
Other Study ID Numbers: RCB1956
First Submitted: August 9, 2013
First Posted: November 18, 2013
Results First Submitted: May 26, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases