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

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

https://becertain.org/projects/diverticulitis-care/cosmid-study/about

COSMID is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL)-limiting diverticulitis. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticulitis, is elective colectomy more effective than best medical management?

The study will aim to investigate and complete the following objectives: Compare patient-reported outcomes such as quality of life in patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management; compare clinical outcomes such as number of subsequent episodes of diverticulitis between patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management; and compare healthcare utilization between patients with QoL-limiting diverticulitis randomized to elective colectomy vs. best medical management.

Participant Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

Unable or unwilling to return or be contacted for and/or complete research surveys;
Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
Previous operation for diverticulitis
Current diagnosis or previous endoscopic or surgical interventions for fistula or stricture or current significant bleeding related to diverticular disease.
Right-sided diverticulitis
Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, “frozen abdomen”)
Actively undergoing chemotherapy or radiation for malignancy
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);
Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn’s, ulcerative colitis);
Taking prescription medication for irritable bowel syndrome;
Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
Abdominal/pelvic surgery in the past month

Contact

Kelsey Pullar
(206) 221-8247