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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 years

• 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)

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UC San Diego Health
RECRUITING
San Diego
UCSF Health
RECRUITING
San Francisco
Stanford University Medical Center
RECRUITING
Stanford
Colorado
University of Colorado
RECRUITING
Denver
Florida
University of Florida
RECRUITING
Gainesville
University of South Florida
RECRUITING
Tampa
Georgia
Memorial Health University Medical Center
RECRUITING
Savannah
Iowa
University of Iowa Healthcare
RECRUITING
Iowa City
Illinois
Rush University Medical Center
RECRUITING
Chicago
Northwestern University
RECRUITING
Evanston
Southern Illinois University School of Medicine
RECRUITING
Springfield
Massachusetts
Boston University Medical Center
RECRUITING
Boston
Lahey Clinic
RECRUITING
Burlington
North Carolina
Atrium Health-Carolinas Medical Center
RECRUITING
Charlotte
New York
Albany Medical College
RECRUITING
Albany
New York Presbyterian-Queens
RECRUITING
Flushing
Columbia University Medical Center
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Mount Carmel Health Systems
RECRUITING
Columbus
Pennsylvania
Penn Medicine
RECRUITING
Philadelphia
Allegheny-Singer Research Institute
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Utah
University of Utah Health
RECRUITING
Salt Lake City
Virginia
VCU Medical Center
RECRUITING
Richmond
Washington
Benaroya Research Institute at Virginia Mason
RECRUITING
Seattle
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Kelsey M Pullar, MPH
kpullar@uw.edu
206 221-8247
Backup
Erin E Fannon
ecarney@uw.edu
206 685-9770
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 250
Treatments
Active_comparator: 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.
Active_comparator: 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.
Sponsors
Leads: University of Washington
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov