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

Last updated: September 20, 2024
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Treatment

Partial Colectomy

Medical Management

Clinical Study ID

NCT04095663
STUDY00007409
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥18 years

  2. At least one episode of diverticulitis confirmed by CT scan (or pendingconfirmation) and a colonoscopy (completed or scheduled) to rule out or screen forother colon pathology concordant with screening guidelines; AND A. History ofrecurrent uncomplicated diverticulitis without current symptoms (AUD in remission);OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3months after recovery from an episode of AUD (e.g., excluding irritable bowelsyndrome and other conditions in coordination with gastroenterologist)

Exclusion

Exclusion Criteria:

  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 (patientswearing 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 orstricture 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, chronicimmunosuppressive 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 followingbaseline/screening;

  12. Prior enrollment in the study or other investigational drug or vaccine while onstudy treatment;

  13. Abdominal/pelvic surgery in the past month

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Partial Colectomy
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
November 01, 2026

Study Description

For over 50 years, professional society recommendations for the management of uncomplicated diverticulitis included early elective surgery to prevent the need for an emergency operation and avoid the risk of colostomy. Over the last 15 years the notion that a patient must have a certain number of episodes of acute uncomplicated diverticulitis (AUD) before undergoing elective colectomy has changed dramatically. This was, in part, due to studies showing that emergency surgery for complicated disease is much more likely to be needed during the first episode of diverticulitis, making the notion of prophylactic elective colectomy for AUD less relevant. Furthermore, clinicians realized that most recurrent episodes of AUD could be managed with outpatient antibiotics alone and that "best medical management" - including fiber supplementation, mesalazine, rifamycin and probiotics - could reduce symptoms between episodes of AUD. All of the components of best medical management have some, albeit limited, evidence of effectiveness, most in improving symptoms rather than reducing the risk of recurrence and are relatively safe and inexpensive. Best medical management is far less invasive than elective surgery but infrequently prescribed the US, in part because of limited insurance coverage. Alternatively, resection removes the diseased segment of colon, does relieve symptoms and decreases the risk of recurrence.

In 2014, guidelines from the American Society of Colorectal Surgeons (ASCRS) abandoned "episode count" as an indication for surgery in patients with AUD and instead recommended individualizing the decision to operate for AUD based on the "effects on lifestyle (professional and personal) of recurrent attacks". Decision making about surgery in patients with lingering symptoms after recovery from an episode of AUD has not been the specific focus of an ASCRS guideline, but recommendations about elective surgery emphasize individualizing decision making based on the overall impact of the disease on the patient.These recommendations for individualization of treatment based on the quality of life (QoL) impact of recurrent AUD and lingering symptoms highlight the decision that hundreds of thousands of people now have to make each year. Based on the effect of the disease on their QoL they must choose between two very different treatment options: elective colectomy vs. best medical management. While the recommendation to individualize treatment based on the QoL impact is a step forward in advancing patient-centered care, the comparative effectiveness of these two treatments on symptoms and QoL has not been well studied.

This will be a multi-site, open randomized trial in which participants with either recurrent AUD or lingering symptoms after an episode of AUD are randomized to one of two initial treatment strategies, elective segmental colectomy (performed laparoscopically when possible) and best medical management.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • UC San Diego Health

    San Diego, California 92103
    United States

    Active - Recruiting

  • UCSF Health

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Colorado

    Denver, Colorado 80045
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Northwestern University

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62794
    United States

    Active - Recruiting

  • University of Iowa Healthcare

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Lahey Clinic

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12208
    United States

    Active - Recruiting

  • New York Presbyterian-Queens

    Flushing, New York 11355
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10027
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Atrium Health-Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Mount Carmel Health Systems

    Columbus, Ohio 43213
    United States

    Active - Recruiting

  • Penn Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • University of Utah Health

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • VCU Medical Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98105
    United States

    Active - Recruiting

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