Status:
RECRUITING
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Diverticulitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Adults ≥18 years
- At least one episode of diverticulitis confirmed by CT scan and a colonoscopy (completed or scheduled) to rule out or screen for other colon pathology in accordance with colorectal cancer screening guidelines
- Persistent signs, symptoms, or concerns related to diverticulitis after recovery from an episode of left-sided diverticulitis
- Self-reported QoL limitation (assessed with 12 questions modified from the Diverticulitis Quality of Life \[DV-QOL\] instrument).
Exclusion
- Unable to consent in English or Spanish
- Current diagnosis or previous endoscopic or surgical interventions for fistula, or stricture or current significant bleeding, related to diverticulitis
- Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place)
- Previous operation for diverticulitis
- Right-sided diverticulitis
- Immunodeficiency (e.g., absolute neutrophil count \<500/mm3, chronic immunosuppressive drugs like oral corticosteroids, anti-TNF agents, or known AIDS \[i.e., recent CD4 count \<200\] assessed by patient history)
- Actively undergoing chemotherapy or radiation for malignancy
- Expectant or concurrent hemodialysis, peritoneal dialysis, treatments using indwelling venous catheters, or conditions putting patient at risk for bacterial seeding
- Diagnosis of inflammatory bowel disease (i.e., Crohn's, ulcerative colitis)
- Taking prescription medication for irritable bowel syndrome
- Intolerance or allergy to all medications in the medical management arm
- Surgeon is unwilling to offer surgery due to comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
- Abdominal/pelvic surgery within the past month
- Pregnant or expecting to become pregnant in the 30 days following baseline/screening
- Unable to consent to research or self-respond to follow-up surveys (e.g., altered mental status)
- Currently incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled)
- Prior enrollment in the COSMID study or planning on enrollment in another investigational drug or vaccine while on study treatment
- Unable or unwilling to return, be contacted for, or complete research surveys.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04095663
Start Date
October 1 2019
End Date
February 1 2027
Last Update
November 13 2025
Active Locations (29)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
UC San Diego Health
San Diego, California, United States, 92103
3
UCSF Health
San Francisco, California, United States, 94143
4
Stanford University Medical Center
Stanford, California, United States, 94305