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Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Sponsor: University of Washington
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
255
Start Date
2019-10-01
Completion Date
2027-02-01
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Partial Colectomy
Most partial colectomies are performed using a laparoscopic approach, when possible, and surgeons sometimes use a temporary, protective stoma if the re-connection is considered high risk.
Medical Management
Patients will be offered a varying combination of tools from the best medical management "toolbox" (diet and exercise, fiber supplementation/probiotics, and rifamycin/mesalazine) depending on what they have already tried. Based on the "evidence-based best medical toolbox" clinicians will be asked to consider rifamycin (dose/frequency) for those with AUD who are not responding to diet and exercise and mesalazine (dose/frequency) for those with lingering symptoms who are not responding to diet and exercise.
Locations (29)
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
University of Utah Health
Salt Lake City, Utah, United States
VCU Medical Center
Richmond, Virginia, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States