Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (COSMID)

Clinical Trial Details

The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized but are willing to contribute information about their outcomes.

The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm.

The purpose of this study is to evaluate whether surgery is better than medical management in the treatment of diverticulitis.

Participants will answer questionnaires. There are approximately 12 phone-based, email-based, mailed, or text-message follow-up surveys to complete.

Key Eligibility:

Adults over the age of 18
At least one episode of diverticulitis confirmed by CT scan (or pending confirmation) and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology concordant with screening guidelines; AND a history of recurrent uncomplicated diverticulitis without current symptoms OR persistent signs, symptoms, and concerns related to diverticular disease more than 3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Primary Investigator(s)

Mehraneh Jafari , MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2309026509

ClinicalTrials.gov:

NCT04095663

Status

Open to Enrollment

Age Group

Adult

Disease

Diverticulitis

Surgery