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

Running, not enrolling · Not applicable

Conditions studied: Diverticulitis

In brief

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.

Key facts

Study ID

NCT04095663

Run by

University of Washington

People needed

255

Starts

2019-10-01

Expected to finish

2027-02-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen") as determined by surgeon
• Abdominal/pelvic surgery within the past month
• Pregnant or expecting to become pregnant in the 30 days following baseline/screening
• Unable to consent to research or self-respond to follow-up surveys (e.g., altered mental status)
• Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening
• Prior enrollment in the COSMID study or planning on enrollment in another investigational drug or vaccine while on study treatment
• Unable or unwilling to return or be contacted for and/or complete research surveys.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC San Diego Health — San Diego, California, United States
• UCSF Health — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• University of Iowa Healthcare — Iowa City, Iowa, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Albany Medical College — Albany, New York, United States
• New York Presbyterian-Queens — Flushing, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Atrium Health-Carolinas Medical Center — Charlotte, North Carolina, United States
• Mount Carmel Health Systems — Columbus, Ohio, United States
• Penn Medicine — Philadelphia, Pennsylvania, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• UTHealth Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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