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

Diverticulitis Clinical Trial

— COSMID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095663
• Other study ID #: STUDY00007409
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diverticulitis

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