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

RECRUITING
I'm interested

18 years and over
This study is NOT accepting healthy volunteers
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

PROCEDURE: Partial Colectomy, OTHER: Medical Management

Diverticulitis

Kelsey M Pullar, MPH - kpullar@uw.edu
Wieghard, Nicole
NA
HM20016794
NCT04095663
See this study on ClinicalTrials.gov

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