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

Last updated: February 17, 2026
Sponsor: University of Washington
Overall Status: Active - Not 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:

  • Adults ≥18 years

  • At least one episode of diverticulitis confirmed by CT scan and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology concordantwith screening guidelines

  • Persistent signs, symptoms, or concerns related to diverticulitis after recoveryfrom an episode of left-sided diverticulitis as confirmed with self-reported QoLlimitation.

Exclusion

Exclusion Criteria:

  • Unable to consent in English or Spanish

  • Current diagnosis or previous endoscopic or surgical interventions for fistula, orstricture or current significant bleeding, related to diverticular disease

  • Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics fordiverticulitis; drain in place)

  • Previous operation for diverticulitis

  • Right-sided diverticulitis

  • Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronicimmunosuppressive drugs like oral corticosteroids, anti-TNF agents, or known AIDS [i.e., recent CD4 count <200] assessed by patient history)

  • Actively undergoing chemotherapy or radiation for malignancy

  • Expectant or concurrent hemodialysis, peritoneal dialysis, treatments usingindwelling venous catheters, or conditions putting patient at risk for bacterialseeding

  • Diagnosis of inflammatory bowel disease (i.e., Crohn's, ulcerative colitis)

  • Taking prescription medication for irritable bowel syndrome

  • Intolerance or allergy to all medications in the medical management arm

  • Comorbid or prior surgical conditions that contraindicate elective surgery (e.g.,liver failure, renal failure, malignancy, "frozen abdomen") as determined by surgeon

  • Abdominal/pelvic surgery within the past month

  • Pregnant or expecting to become pregnant in the 30 days following baseline/screening

  • Unable to consent to research or self-respond to follow-up surveys (e.g., alteredmental status)

  • Currently incarcerated in a detention facility or in police custody (patientswearing a monitoring device can be enrolled) at baseline/screening

  • Prior enrollment in the COSMID study or planning on enrollment in anotherinvestigational drug or vaccine while on study treatment

  • Unable or unwilling to return or be contacted for and/or complete research surveys.

Study Design

Total Participants: 255
Treatment Group(s): 2
Primary Treatment: Partial Colectomy
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
February 01, 2027

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

    Site Not Available

  • UC San Diego Health

    San Diego, California 92103
    United States

    Site Not Available

  • UCSF Health

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • UC San Diego Health

    San Diego 5391811, California 5332921 92103
    United States

    Site Not Available

  • UCSF Health

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • University of Colorado

    Denver, Colorado 80045
    United States

    Site Not Available

  • University of Colorado

    Denver 5419384, Colorado 5417618 80045
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of Florida

    Gainesville 4156404, Florida 4155751 32608
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah 4221552, Georgia 4197000 31404
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Northwestern University

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • University of Iowa Healthcare

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Healthcare

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Lahey Clinic

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Boston University Medical Center

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Site Not Available

  • Lahey Clinic

    Burlington 4931737, Massachusetts 6254926 01805
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • New York Presbyterian-Queens

    Flushing, New York 11355
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10027
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14618
    United States

    Site Not Available

  • Albany Medical College

    Albany 5106834, New York 5128638 12208
    United States

    Site Not Available

  • New York Presbyterian-Queens

    Flushing 5117472, New York 5128638 11355
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10027
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14618
    United States

    Site Not Available

  • Atrium Health-Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Atrium Health-Carolinas Medical Center

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Site Not Available

  • Mount Carmel Health Systems

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Mount Carmel Health Systems

    Columbus 4509177, Ohio 5165418 43213
    United States

    Site Not Available

  • Penn Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Penn Medicine

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Allegheny-Singer Research Institute

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • UTHealth Houston

    Houston 4699066, Texas 4736286 77026
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • VCU Medical Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • VCU Medical Center

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington 98101
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Benaroya Research Institute at Virginia Mason

    Seattle 5809844, Washington 5815135 98101
    United States

    Site Not Available

  • University of Washington

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

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