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

Description

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.

Conditions

Diverticulitis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diverticulitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

San Diego

UC San Diego Health, San Diego, California, United States, 92103

San Francisco

UCSF Health, San Francisco, California, United States, 94143

Stanford

Stanford University Medical Center, Stanford, California, United States, 94305

Denver

University of Colorado, Denver, Colorado, United States, 80045

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Savannah

Memorial Health University Medical Center, Savannah, Georgia, United States, 31404

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Evanston

Northwestern University, Evanston, Illinois, United States, 60201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adults ≥18 years
  • 2. 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 (AUD in remission); OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)
  • 1. Unable or unwilling to return or be contacted for and/or complete research surveys;
  • 2. Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
  • 3. Previous operation for diverticulitis
  • 4. Current diagnosis or previous endoscopic or surgical interventions for fistula or stricture or current significant bleeding related to diverticular disease.
  • 5. Right-sided diverticulitis
  • 6. Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
  • 7. Actively undergoing chemotherapy or radiation for malignancy
  • 8. Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs (e.g., oral corticosteroids, anti-TNF agents), or known AIDS \[i.e., recent CD4 count \<200 \] assessed by patient history);
  • 9. Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
  • 10. Taking prescription medication for irritable bowel syndrome;
  • 11. Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
  • 12. Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
  • 13. Abdominal/pelvic surgery in the past month

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

David R Flum, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2026-11-01