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ACTIVE NOT RECRUITING
NCT04095663
NA

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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

PROCEDURE

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.

OTHER

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