Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
NCT ID: NCT04095663
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2019-10-01
2027-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Partial Colectomy
Elective segmental colectomy for diverticular disease involves removal of the segment of colon (most commonly sigmoid and/or left colon) where there has been disease identified by computed tomography imaging or colonoscopy. Elective colectomy usually removes the affected colon along with adjacent segments that have diverticula, with a primary anastomosis performed to reestablish bowel continuity. Most surgeons now perform the procedure using a laparoscopic approach, when possible, and sometimes use a temporary, protective stoma if the re-connection is considered high-risk. The technique for laparoscopic resection is not specified by the protocol (allows for any number of laparoscopic port sites, all incision types, hand-assistance and robotic) with details of the technique recorded. If randomized to elective colectomy, patients will be encouraged to undergo the procedure within 6 weeks of assignment.
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.
Medical Management
Medical management for diverticular disease has been used for over 30 years and includes a set of interventions, all components of which have been the subject of small, but often positive trials. All patients randomized to medical management or who select it as their treatment in the observational cohort will view a video (provided in English and Spanish) that explains each element of the medical management "toolbox": diet and exercise recommendations, fiber supplementation (e.g., augmenting dietary fiber or over the counter fiber supplements), with mesalazine tablets or suppositories, probiotics and rifamycin. In consultation with their physician, they will be recommended to a regimen of diet and exercise and fiber supplementation. 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 in accordance with colorectal cancer screening guidelines
* Persistent signs, symptoms, or concerns related to diverticulitis after recovery from an episode of left-sided diverticulitis
* Self-reported QoL limitation (assessed with 12 questions modified from the Diverticulitis Quality of Life \[DV-QOL\] instrument).
Exclusion Criteria
* Current diagnosis or previous endoscopic or surgical interventions for fistula, or stricture or current significant bleeding, related to diverticulitis
* 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
* Surgeon is unwilling to offer surgery due to comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
* 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 at baseline/screening (patients wearing a monitoring device can be enrolled)
* 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, be contacted for, or complete research surveys.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Washington
OTHER
Responsible Party
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David Flum
Professor, School of Medicine: Surgery
Principal Investigators
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David R Flum, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jenny Broering
Role: primary
Kristen Davis
Role: primary
Tracey MacDermott
Role: primary
Amber Bouton
Role: primary
Avennette Pinto
Role: primary
Anne Brooks
Role: primary
Matthew Johnson
Role: primary
Rose Arrieta
Role: primary
Jessica Danielson
Role: primary
Marina Malikova
Role: primary
Kameron Ky
Role: primary
Susan Ingenito
Role: primary
Ken Watanabe
Role: primary
Jordan Augsburger
Role: primary
I Marianetti
Role: primary
Colie Kaiser
Role: primary
Sheila Brooks
Role: primary
Rachel Reading
Role: primary
Natalie Koren
Role: primary
Debbie Nguyen
Role: primary
Jordan Esplin
Role: primary
Jinfeng Han
Role: primary
Audrey Merz
Role: primary
Mariam Hantouli, MD
Role: primary
Kelsey Pullar, MPH
Role: backup
Other Identifiers
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STUDY00007409
Identifier Type: -
Identifier Source: org_study_id