Surgery vs Medicine for Diverticulitis
(COSMID Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares surgery (removing part of the colon) with a combination of medications and lifestyle changes for patients whose diverticular disease affects their quality of life. It aims to find out which treatment helps these patients feel better and live more comfortably.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications for inflammatory bowel disease or irritable bowel syndrome, you may not be eligible to participate.
Is surgery or medical management for diverticulitis safe?
Research suggests that non-surgical management, which includes antibiotics and supportive care, is safe for over 70% of patients with diverticulitis. For those needing surgery, minimally invasive procedures like laparoscopic colectomy have shown improved safety outcomes, especially in patients with other health issues.12345
How does the treatment of surgery vs medicine for diverticulitis differ from other treatments?
This treatment is unique because it compares medical management, which often involves antibiotics and dietary changes, with surgical options like partial colectomy (removal of part of the colon), which is typically reserved for patients with a high risk of recurrence or when conservative treatments fail. The choice between these approaches depends on the severity of the condition and the patient's overall health.678910
What data supports the effectiveness of this treatment for diverticulitis?
Recent studies suggest that non-surgical management, which includes medical and conservative treatments, can be as effective as surgery for many patients with uncomplicated diverticulitis. However, surgery may still be necessary for those with complicated cases or for immunocompromised patients, where medical treatment often fails.78111213
Who Is on the Research Team?
David R Flum, MD
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either elective segmental colectomy or best medical management
Follow-up
Participants are monitored for quality of life and symptoms using the GIQLI at 6, 9, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Medical Management
- Partial Colectomy
Medical Management is already approved in United States, European Union for the following indications:
- Uncomplicated Diverticulitis
- Chronic Diverticular Disease
- Uncomplicated Diverticulitis
- Recurrent Diverticulitis
- Chronic Diverticular Disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator