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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Diverticulitis: A Randomized Controlled Trial

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Stony Brook University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Stony Brook University

Dates:
Date Received: August 9, 2013
Date Started: October 2011
Date Completion: December 2015
Last Updated: May 26, 2015
Last Verified: May 2015