N/A
N=107
Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
Diverticulitis
Bottom Line
View on ClinicalTrials.gov: NCT01986686 ↗Enrolled (actual)
107
Serious AEs
1.9%
Results posted
Oct 2017
Primary outcome: Primary: Primary Study Endpoint — 26; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colon resection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Study Endpoint |
26; 2 | — |
| SECONDARY Measure Length of Hospital Stay for Surgery vs Non Surgery Patients |
— | — |
| SECONDARY Mortality |
— | — |
| SECONDARY Readmission |
— | — |
| SECONDARY Post Operative Complications |
— | — |
| SECONDARY Recurrence and Treatment |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01986686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.