Diverticulitis trial looks to optimize disease care, improve patient quality of life

For the past several decades, the standard of care for patients with uncomplicated diverticulitis included early elective surgery with the goal of averting the need for an emergency procedure and potential colostomy.

Now, with the goal of improving patients’ quality of life, the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is in the process of determining whether medical management or colectomy are the best treatment option for patients with repeated episodes of acute uncomplicated diverticulitis.

Currently, the majority of mechanisms behind medical therapy for the disease, ranging from dietary focuses like fiber supplementation to mesalamine and rifaximin, are relatively safe for patients. But their degree of efficacy is limited; most positive trials evaluating medical therapies for diverticulitis demonstrated a reduction in chronic symptoms as opposed to a decrease in reoccurrence of diverticulitis.

Resection of the diseased colon has the advantage of relieving acute symptoms and reducing the risk of recurrence. However, it is less clear whether colectomy will relieve chronic gastrointestinal symptoms in these patients, especially those associated with concomitant functional bowel disorders. In addition, surgery carries with it 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 vs surgical therapy on symptoms and quality of life hasn’t been well studied.

In fact, there has been only one previous trial randomizing patients to medicine versus surgery for diverticulitis. “Adding another nationwide randomized trial offers hope for patients whose diverticulitis limits their

quality of life,” said Thomas E. Read, M.D., FACS, FASCRS, Cracchiolo professor and chief of the UF division of gastrointestinal surgery, is serving as the chair of the national clinical advisory group for the COSMID trial.

“The disease is one of the most common we see, and it is our mission that this randomized trial will guide us as to optimizing treatment for these patients,” Read said.

The COSMID trial, a pragmatic trial with minimal exclusion criteria, will be heterogeneous with regard to patients and practice types. It involves more than 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.

Following a patient’s randomization to surgery or medical therapy, primary metrics of evaluation will focus on assessing the patient’s gastrointestinal quality of life at six months and one year. Researchers will also document whether or not patients experienced repeated episodes of diverticulitis, adverse events, and required health care resources like hospitalization and the ER.

COSMID (ClinicalTrials.gov Identifier NCT04095663), funded by the Patient-Centered Outcomes Research Institute, has now enrolled more patients than any similar trial to date, and UF is one of the top contributors. 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.