Recurrence Following CT-guided Drainage of 1st Episode Hinchey II Diverticulitis
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Diverticulitis: A Randomized Controlled Trial|
- 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.
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01986686
|Contact: Danielle B Devlin, B.S.||firstname.lastname@example.org|
|United States, New York|
|Stony Brook Medicine||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Joan A Kavanaugh, BS 631-444-3036 email@example.com|
|Contact: Danielle Devlin, BS 631-638-2215 firstname.lastname@example.org|
|Principal Investigator: Roberto C Bergamaschi, MD, PhD|
|Principal Investigator:||Roberto C Bergamaschi, MD, PhD||Stonybrook University|