Back to resultsRecurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
Primary Purpose
Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colon resection
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis
Eligibility 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
Sites / Locations
- Stony Brook Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Observational
Surgery
Arm Description
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
The surgery group will be offered colon resection.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Mortality
Data will be collected on percent of patients who die during the follow-up period after enrollment.
Readmission
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
Data will be collected on percent and type of complications for the surgery arm.
Recurrence and Treatment
Data will be collected on recurrence and treatment for recurrent diverticulitis
Full Information
NCT ID
NCT01986686
First Posted
August 9, 2013
Last Updated
May 26, 2017
Sponsor
Stony Brook University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01986686
Brief Title
Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 16, 2016 (Actual)
Study Completion Date
July 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observational
Arm Type
No Intervention
Arm Description
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
The surgery group will be offered colon resection.
Intervention Type
Procedure
Intervention Name(s)
Colon resection
Intervention Description
Elective robotic/laparoscopic/open colon resection for diverticular disease.
Primary Outcome Measure Information:
Title
Primary Study Endpoint
Description
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 Outcome Measure Information:
Title
Measure Length of Hospital Stay for Surgery vs Non Surgery Patients
Description
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
Title
Mortality
Description
Data will be collected on percent of patients who die during the follow-up period after enrollment.
Time Frame
4 years
Title
Readmission
Description
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
Title
Post Operative Complications
Description
Data will be collected on percent and type of complications for the surgery arm.
Time Frame
30 days
Title
Recurrence and Treatment
Description
Data will be collected on recurrence and treatment for recurrent diverticulitis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto C Bergamaschi, MD, PhD
Organizational Affiliation
Stonybrook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29683483
Citation
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.
Results Reference
derived
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Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
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