Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (COSMID)
Diverticulitis
About this trial
This is an interventional treatment trial for Diverticulitis
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical CenterRecruiting
- UC San Diego HealthRecruiting
- UCSF HealthRecruiting
- Stanford University Medical CenterRecruiting
- University of ColoradoRecruiting
- University of FloridaRecruiting
- University of South FloridaRecruiting
- Memorial Health University Medical CenterRecruiting
- Rush University Medical CenterRecruiting
- Northwestern UniversityRecruiting
- Southern Illinois University School of MedicineRecruiting
- University of Iowa HealthcareRecruiting
- Boston University Medical CenterRecruiting
- Lahey ClinicRecruiting
- Albany Medical CollegeRecruiting
- New York Presbyterian-QueensRecruiting
- Columbia University Medical CenterRecruiting
- University of Rochester Medical CenterRecruiting
- Atrium Health-Carolinas Medical CenterRecruiting
- Mount Carmel Health SystemsRecruiting
- Penn MedicineRecruiting
- Allegheny-Singer Research InstituteRecruiting
- Medical University of South CarolinaRecruiting
- UT Southwestern Medical CenterRecruiting
- University of Utah HealthRecruiting
- VCU Medical CenterRecruiting
- Benaroya Research Institute at Virginia MasonRecruiting
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Partial Colectomy
Medical Management
Elective segmental colectomy for diverticular disease involves removal of the segment of colon (most commonly sigmoid and/or left colon) where there has been disease identified by computed tomography imaging or colonoscopy. Elective colectomy usually removes the affected colon along with adjacent segments that have diverticula, with a primary anastomosis performed to reestablish bowel continuity. Most surgeons now perform the procedure using a laparoscopic approach, when possible, and sometimes use a temporary, protective stoma if the re-connection is considered high-risk. The technique for laparoscopic resection is not specified by the protocol (allows for any number of laparoscopic port sites, all incision types, hand-assistance and robotic) with details of the technique recorded. If randomized to elective colectomy, patients will be encouraged to undergo the procedure within 6 weeks of assignment.
Medical management for diverticular disease has been used for over 30 years and includes a set of interventions, all components of which have been the subject of small, but often positive trials. All patients randomized to medical management or who select it as their treatment in the observational cohort will view a video (provided in English and Spanish) that explains each element of the medical management "toolbox": diet and exercise recommendations, fiber supplementation (e.g., augmenting dietary fiber or over the counter fiber supplements), with mesalazine tablets or suppositories, probiotics and rifamycin. In consultation with their physician, they will be recommended to a regimen of diet and exercise and fiber supplementation. Clinicians will be asked to consider rifamycin (dose/frequency) for those with AUD who are not responding to diet and exercise and mesalazine (dose/frequency) for those with lingering symptoms who are not responding to diet and exercise.