StudyFinder
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
RECRUITING
18 years and over
Inclusion Criteria:
* 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 Criteria:
* 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.PROCEDURE: Partial Colectomy, OTHER: Medical Management
Diverticulitis
Kelsey M Pullar, MPH - kpullar@uw.edu
Wieghard, Nicole
HM20016794
NCT04095663
See this study on ClinicalTrials.gov