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Surgery or pills? new study tackles diverticulitis dilemma

NCT ID NCT04095663

Symptom relief Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares surgery (removing part of the colon) to the best medical treatments for people whose diverticulitis symptoms seriously affect their daily life. About 255 adults with at least one confirmed episode of diverticulitis and ongoing quality-of-life issues are taking part. The goal is to see which approach—surgery or medicine—better improves how patients feel and function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 concordant with screening guidelines * Persistent signs, symptoms, or concerns related to diverticulitis after recovery from an episode of left-sided diverticulitis as confirmed with self-reported QoL limitation. Exclusion Criteria: * Unable to consent in English or Spanish * Current diagnosis or previous endoscopic or surgical interventions for fistula, or stricture or current significant bleeding, related to diverticular disease * Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place) * Previous operation for diverticulitis * Right-sided diverticulitis * Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive 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 using indwelling venous catheters, or conditions putting patient at risk for bacterial seeding * 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., altered mental status) * Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening * Prior enrollment in the COSMID study or planning on enrollment in another investigational drug or vaccine while on study treatment * Unable or unwilling to return or be contacted for and/or complete research surveys.

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Conditions

The condition(s) this trial relates to.

diverticulitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diverticulitis

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Atrium Health-Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101, United States

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center

    New York, New York, 10027, United States

  • Lahey Clinic

    Burlington, Massachusetts, 01805, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mount Carmel Health Systems

    Columbus, Ohio, 43213, United States

  • New York Presbyterian-Queens

    Flushing, New York, 11355, United States

  • Northwestern University

    Evanston, Illinois, 60201, United States

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • UC San Diego Health

    San Diego, California, 92103, United States

  • UCSF Health

    San Francisco, California, 94143, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UTHealth Houston

    Houston, Texas, 77026, United States

  • University of Colorado

    Denver, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Iowa Healthcare

    Iowa City, Iowa, 52242, United States

  • University of Rochester Medical Center

    Rochester, New York, 14618, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Utah Health

    Salt Lake City, Utah, 84112, United States

  • University of Washington

    Seattle, Washington, 98105, United States

  • VCU Medical Center

    Richmond, Virginia, 23298, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.