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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04095663
Other study ID # STUDY00007409
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date January 1, 2026

Study information

Verified date September 2023
Source University of Washington
Contact Kelsey M Pullar, MPH
Phone 206 221-8247
Email kpullar@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 330
Est. completion date January 1, 2026
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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) 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 (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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Other:
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.

Locations

Country Name City State
United States Albany Medical College Albany New York
United States Boston University Medical Center Boston Massachusetts
United States Lahey Clinic Burlington Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Atrium Health-Carolinas Medical Center Charlotte North Carolina
United States Rush University Medical Center Chicago Illinois
United States Mount Carmel Health Systems Columbus Ohio
United States UT Southwestern Medical Center Dallas Texas
United States University of Colorado Denver Colorado
United States Northwestern University Evanston Illinois
United States New York Presbyterian-Queens Flushing New York
United States University of Florida Gainesville Florida
United States University of Iowa Healthcare Iowa City Iowa
United States Cedars-Sinai Medical Center Los Angeles California
United States Columbia University Medical Center New York New York
United States Penn Medicine Philadelphia Pennsylvania
United States Allegheny-Singer Research Institute Pittsburgh Pennsylvania
United States VCU Medical Center Richmond Virginia
United States University of Rochester Medical Center Rochester New York
United States University of Utah Health Salt Lake City Utah
United States UC San Diego Health San Diego California
United States UCSF Health San Francisco California
United States Memorial Health University Medical Center Savannah Georgia
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States University of Washington Seattle Washington
United States Southern Illinois University School of Medicine Springfield Illinois
United States Stanford University Medical Center Stanford California
United States University of South Florida Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI) The primary outcome of mean GIQLI at 6, 9, and 12 months will be assessed using an ANCOVA regression model that adjusts for an indicator of randomized treatment group, the GIQLI score as measured at baseline prior to randomization, as well as factors used to stratify randomization. Mean GIQLI at 6, 9, and 12 months following randomization to treatment
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