Active — Not RecruitingNot Applicable

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

United States255 participantsStarted 2019-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ≥18 years * At least one episode of diverticulitis confirmed by CT scan and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology concordant with screening guidelines * Persistent signs, symptoms, or concerns related to diverticulitis after recovery from an episode of left-sided diverticulitis as confirmed with self-reported QoL limitation. Exclusion Criteria: * Unable to consent in English or Spanish * Current diagnosis or previous endoscopic or surgical interventions for fistula, or stricture or current significant bleeding, related to diverticular disease * Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place) * Previous operation for diverticulitis * Right-sided diverticulitis * Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs like oral corticosteroids, anti-TNF agents, or known AIDS \[i.e., recent CD4 count \<200\] assessed by patient history) * Actively undergoing chemotherapy or radiation for malignancy * Expectant or concurrent hemodialysis, peritoneal dialysis, treatments using indwelling venous catheters, or conditions putting patient at risk for bacterial seeding * Diagnosis of inflammatory bowel disease (i.e., Crohn's, ulcerative colitis) * Taking prescription medication for irritable bowel syndrome * Intolerance or allergy to all medications in the medical management arm * Comorbid or prior surg…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)

Timeframe: Mean GIQLI at 6, 9, and 12 months following randomization to treatment

Trial details

NCT IDNCT04095663

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

View on ClinicalTrials.gov More Diverticulitis trials