Trial record 5 of 20 for:    Open Studies | "Diverticulitis"

Recurrence Following CT-guided Drainage of 1st Episode Hinchey II Diverticulitis

This study is currently recruiting participants.
Verified November 2013 by Stony Brook University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01986686
First received: August 9, 2013
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

Patients will agree to be randomized to either surgery or non-operative management following a first episode of Hinchey II diverticulitis. Information will also be collected on rates of recurrence rates and major complications in both groups.


Condition
Diverticulitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diverticulitis: 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: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measure length of hospital stay for surgery vs non surgery patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Data will be collected on percentage of patients who require emergency surgery after first episode of diverticulitis

  • Fistula necessitating surgery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Data will be collected on percent of patients who undergo fistula surgery after 1st episode of diverticulitis

  • Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Data will be collected on percent of patients who die after first episode diverticulitis due to treatment complications

  • Readmission [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Data will be collected on percent and type of complications for post surgery patients

  • Recurrence and treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    data will be collected on recurrence and treatment for recurrence of diverticulitis


Estimated Enrollment: 75
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
Surgery
The surgery group will be offered colon resection.

Detailed Description:

This study will test the feasibility of randomizing patients with a first episode of diverticulitis with abscess defined by CT scan amenable to drainage to observation or elective sigmoid resection. The study will also gather preliminary data on relative safety of surgery and observation.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with successfully treated first episode diverticulitis and intraabdominal abscess

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(see Appendix A)
  • the diagnosis confirmed by colonoscopy
  • Signed informed consent

Exclusion Criteria:

  • Abscess not amenable to percutaneous drainage
  • 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
  • Patients who are unable to sign the informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01986686

Contacts
Contact: Danielle B Devlin, B.S. 631-638-2215 danielle.devlin@stonybrook.edu

Locations
United States, New York
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794
Contact: Joan A Kavanaugh, BS    631-444-3036    joan.kavanaugh@stonybrook.edu   
Contact: Danielle Devlin, BS    631-638-2215    danielle.devlin@stonybrook.edu   
Principal Investigator: Roberto C Bergamaschi, MD, PhD         
Sponsors and Collaborators
Stony Brook University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Roberto C Bergamaschi, MD, PhD Stonybrook University
  More Information

No publications provided

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01986686     History of Changes
Other Study ID Numbers: RCB1956
Study First Received: August 9, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014