RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-10-01

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04095663

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Kelsey M Pullar, MPH

CONTACT

206 221-8247

kpullar@uw.edu

Erin E Fannon

CONTACT

206 685-9770

ecarney@uw.edu

Principal Investigator

David R Flum, MD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

UC San Diego Health

San Diego, California, 92103

United States

UCSF Health

San Francisco, California, 94143

United States

Stanford University Medical Center

Stanford, California, 94305

United States

University of Colorado

Denver, Colorado, 80045

United States

University of Florida

Gainesville, Florida, 32608

United States

University of South Florida

Tampa, Florida, 33606

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Northwestern University

Evanston, Illinois, 60201

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62794

United States

University of Iowa Healthcare

Iowa City, Iowa, 52242

United States

Boston University Medical Center

Boston, Massachusetts, 02118

United States

Lahey Clinic

Burlington, Massachusetts, 01805

United States

Albany Medical College

Albany, New York, 12208

United States

New York Presbyterian-Queens

Flushing, New York, 11355

United States

Columbia University Medical Center

New York, New York, 10027

United States

University of Rochester Medical Center

Rochester, New York, 14618

United States

Atrium Health-Carolinas Medical Center

Charlotte, North Carolina, 28203

United States

Mount Carmel Health Systems

Columbus, Ohio, 43213

United States

Penn Medicine

Philadelphia, Pennsylvania, 19104

United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Utah Health

Salt Lake City, Utah, 84112

United States

VCU Medical Center

Richmond, Virginia, 23298

United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101

United States

University of Washington

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: University of Washington

David R Flum, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2019-10-01

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

Diverticulitis