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Surgery vs Medicine for Diverticulitis (COSMID Trial)
N/A
Recruiting
Led By David R Flum, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Adults ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean giqli at 6, 9, and 12 months following randomization to treatment
Awards & highlights
COSMID Trial Summary
This trial is testing whether or not surgery is better than medical management for people with diverticular disease who are having quality of life issues. There is a parallel observational cohort for people who don't want to be randomized, but are willing to contribute information about their outcomes.
Who is the study for?
Adults over 18 with a history of recurrent diverticulitis confirmed by CT and colonoscopy, who are currently symptom-free or have persistent symptoms for more than 3 months after an episode. Not eligible if they have right-sided diverticulitis, take certain medications for bowel diseases, had previous surgeries for diverticulitis, are pregnant or planning to become pregnant soon, or have conditions that rule out surgery.Check my eligibility
What is being tested?
The COSMID trial is testing whether elective colectomy (a type of surgery) is more effective than the best medical management in improving quality of life for patients with problematic diverticular disease. Patients will either undergo surgery or receive medical treatment based on random assignment.See study design
What are the potential side effects?
Possible side effects from the surgical intervention may include typical risks associated with operations such as infection, bleeding, and reactions to anesthesia. Medical management could cause side effects related to medication like stomach upset, allergic reactions or other drug-specific issues.
COSMID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one confirmed diverticulitis episode and a colonoscopy.
Select...
I am 18 years old or older.
COSMID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mean giqli at 6, 9, and 12 months following randomization to treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean giqli at 6, 9, and 12 months following randomization to treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported quality of life as measured by Gastrointestinal Quality of Life Index (GIQLI)
COSMID Trial Design
2Treatment groups
Active Control
Group I: Partial ColectomyActive Control1 Intervention
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.
Group II: Medical ManagementActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,436 Total Patients Enrolled
2 Trials studying Diverticulitis
493 Patients Enrolled for Diverticulitis
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,997,128 Total Patients Enrolled
David R Flum, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have conditions like liver or kidney failure that prevent surgery.I have had at least one confirmed diverticulitis episode and a colonoscopy.I am on medication for Crohn's disease or ulcerative colitis.I am on medication for irritable bowel syndrome.I have a history of simple diverticulitis without current symptoms or ongoing issues related to diverticular disease.I have had surgery for diverticulitis before.I have a weak immune system due to low neutrophil count, use of immunosuppressive drugs, or AIDS.I am 18 years old or older.I cannot or do not want to complete follow-up surveys for the study.I had surgery in my abdomen or pelvis area within the last month.I have had surgery or procedures for fistula, stricture, or bleeding due to diverticular disease.I am currently receiving chemotherapy or radiation for cancer.I have diverticulitis on the right side of my colon.
Research Study Groups:
This trial has the following groups:- Group 1: Partial Colectomy
- Group 2: Medical Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diverticulitis Patient Testimony for trial: Trial Name: NCT04095663 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies at this clinical study for participants?
"Affirmative. Clinicaltrials.gov has registered that this clinical trial is currently accepting volunteers, which was first posted on October 1st 2019 and recently modified on January 28th 2022. The aim of the study is to involve 500 patients from one medical facility."
Answered by AI
To what extent has enrollment been successful in this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this research endeavour is currently recruiting participants and was initially posted on October 1st 2019; it has recently been updated on January 28th 2022. The trial wishes to enroll 500 individuals at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
University of Washington
Lahey Clinic
Benaroya Research Institute at Virginia Mason
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have avoided surgery due to the post surgical conditions (eeewww). I am interested in the observational study. I am already on meds recovering from a recent episode. Treated at lahey.
PatientReceived no prior treatments
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