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

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ClinicalTrials.gov Identifier: NCT01986686
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stony Brook University

Tracking Information
First Submitted Date  ICMJE August 9, 2013
First Posted Date  ICMJE November 18, 2013
Results First Submitted Date  ICMJE May 26, 2017
Results First Posted Date  ICMJE October 18, 2017
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE October 2011
Actual Primary Completion Date July 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Primary Study Endpoint [ Time Frame: 3 years ]
The primary outcome in this feasibility study is whether or not patients will agree to be in the trial. Eligible patients will be approached and we will record what proportion of patients agree to participate. For those who decline enrollment, we will ascertain what aspect of the study is not acceptable to them.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • Measure Length of Hospital Stay for Surgery vs Non Surgery Patients [ Time Frame: 3 years ]
    data collected will include length of hospital stay for patients undergoing surgery from day of surgery to discharge day as compared to observation group
  • Emergency surgery [ Time Frame: 2 years ]
    Data will be collected on percentage of patients who require emergency surgery after first episode of diverticulitis
  • Fistula necessitating surgery [ Time Frame: 2 years ]
    Data will be collected on percent of patients who undergo fistula surgery after 1st episode of diverticulitis
  • Mortality [ Time Frame: 2 years ]
    Data will be collected on percent of patients who die after first episode diverticulitis due to treatment complications
  • Readmission [ Time Frame: 30 days ]
    Data will be collected on percentage of patients readmitted to hospital within 30 days due to complication of treatment
  • Post Operative Complications [ Time Frame: 30 days ]
    Data will be collected on percent and type of complications for post surgery patients
  • Recurrence and Treatment [ Time Frame: 2 years ]
    data will be collected on recurrence and treatment for recurrence of diverticulitis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
Official Title  ICMJE Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diverticulitis
Intervention  ICMJE Procedure: Colon resection
Elective robotic/laparoscopic/open colon resection for diverticular disease.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Colon resection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2017)
107
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2013)
75
Actual Study Completion Date  ICMJE July 16, 2016
Actual Primary Completion Date July 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986686
Other Study ID Numbers  ICMJE RCB1956
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Roberto C Bergamaschi, MD, PhD Stonybrook University
PRS Account Stony Brook University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP