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

Launched by UNIVERSITY OF WASHINGTON · Sep 18, 2019

Keywords

ClinConnect Summary

The COSMID trial is a research study aimed at understanding whether surgery or medicine is more effective for patients suffering from diverticulitis, a condition that can severely affect quality of life. Specifically, it compares elective colectomy (a type of surgery that removes part of the colon) to the best available medical treatments for those with recurrent or persistent symptoms related to diverticular disease. The study hopes to find out if patients who undergo surgery report better outcomes than those who receive medical management alone.

To participate in this trial, you need to be at least 18 years old, have had at least one confirmed episode of diverticulitis, and meet certain health criteria that indicate you are experiencing ongoing issues related to the disease. Participants can expect to be randomly assigned to either the surgery or the medical management group, and there will also be an option for those who prefer not to be randomized to still contribute to the study by sharing their experiences. This trial is currently recruiting participants, and it aims to provide valuable insights into the best treatment options for individuals with diverticulitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults ≥18 years
• • 2. 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:
• • 1. Unable or unwilling to return or be contacted for and/or complete research surveys;
• • 2. Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
• • 3. Previous operation for diverticulitis
• • 4. Current diagnosis or previous endoscopic or surgical interventions for fistula or stricture or current significant bleeding related to diverticular disease.
• • 5. Right-sided diverticulitis
• • 6. Comorbid or prior surgical conditions that contraindicate elective surgery (e.g., liver failure, renal failure, malignancy, "frozen abdomen")
• • 7. Actively undergoing chemotherapy or radiation for malignancy
• • 8. 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);
• • 9. Taking prescription medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
• • 10. Taking prescription medication for irritable bowel syndrome;
• • 11. Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
• • 12. Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
• • 13. Abdominal/pelvic surgery in the past month