University of Florida Surgeon is Chief Advisor to Trial of Surgery Versus Medical Therapy for Diverticulitis
Diverticulitis, the inflammation of pouches (diverticula) in intestines, can be acute or chronic. Over time, this can lead to a bowel obstruction, and other symptoms negatively affecting patient quality of life.
For those who have recurrent episodes of acute, uncomplicated diverticulitis, it is unclear whether medical management or colectomy will result in the best outcome. Most components of medical therapy for the disease — like fiber supplements, anti-inflammatory drugs and probiotics — are relatively safe.
However, evidence of effectiveness has been limited. Most positive trials demonstrate a reduction in chronic symptoms with medical therapy rather than a reduction in risk of recurrence.
Resection of the diseased colon has the advantage of relieving acute symptoms and reducing the risk of recurrence. But it is less clear whether colectomy will relieve chronic gastrointestinal symptoms in these patients, especially those associated with related functional bowel disorders. Surgery also runs the risk of perioperative morbidity.
Clear guidelines as to who should be offered colectomy are lacking, and professional societies recommend individualizing decisions. This lack of consensus arises from a lack of good data. The effect of medical versus surgical therapy on symptoms and quality of life hasn’t been well studied — until now.
Thomas Read, MD, FACS, FASCRS, professor and chief of the UF division of gastrointestinal surgery, is serving as the chair of the national clinical advisory group for the Comparison of Surgery and Medicine on the Impact of Diverticulitis, or COSMID, trial. This nationwide randomized trial will compare surgery and best medical management in adults who have diverticulitis that limits their quality of life.
“Diverticulitis is incredibly common and there has been a paucity of randomized trials to guide us as how best to treat these patients,” Read said. “There has been only one previous trial randomizing patients to medicine versus surgery for diverticulitis, the DIRECT trial.”
That study, conducted in the Netherlands, found that quality of life was better in the group treated with colectomy, despite the relatively high rates of anastomotic leak and colostomy construction in the surgical group. It is unclear whether the findings in the DIRECT trial are broadly applicable, given the modest number of subjects enrolled and the strict inclusion criteria.
In contrast, the COSMID trial, a pragmatic trial with minimal exclusion criteria, will be heterogeneous with regard to patients and practice types. It involves 25 academic, community and county hospitals across 13 states that care for patients with a wide range of demographic characteristics. In addition, the COSMID protocol allows for variations in practice that occur because of this diversity of patients and practice settings.
For example, while the protocol recommends laparoscopic surgery when possible, it allows for open procedures as well. There will be similar variation in the way clinicians prescribe medical management, to work around insurance restrictions that make the cost of some agents prohibitive, and personal preference.
“The question we’re asking is what is a patient’s gastrointestinal quality of life six months and one year after they’re randomized to medical therapy or surgery,” Read explained. Secondary outcomes will include rates of recurrent episodes of diverticulitis, adverse events and types of health care utilization, such as hospitalization, emergency room visits and outpatient visits.
COSMID, funded by the Patient-Centered Outcomes Research Institute, is enrolling now with a target of 500 participants (ClinicalTrials.gov Identifier NCT04095663). The estimated primary completion date is March 2023. The pragmatic nature of the trial should produce robust results that are applicable to general practice and help physicians and patients make more informed treatment decisions.