Safiya Al-Masrouri, MD, MSc1, Ebram Salama, MD1, Sebastien Lachance, MD, FRCSC1, Sarah Faris-Sabboobeh, MSc2, Julie Savard, RN2, Nancy Morin, MD, FRCSC2, Carol-Ann Vasilevsky, MD, FRCSC2, Gabriela Ghitulescu, MD, FRCSC2, Julio Faria, MD, FRCSC2, Marylise Boutros, MD, FRCSC2. 1McGill University, 2Jewish General Hospital
INTRODUCTION: Antibiotics remain the mainstay of treatment of uncomplicated diverticulitis in North America despite recent European literature challenging their utility. This pilot study assesses the feasibility of the first North American randomized controlled trial for outpatient non-antibiotic management of uncomplicated diverticulitis (clinicaltrials.gov identifier-NCT03146091).
METHODS AND PROCEDURES: After institutional review board approval, adults presenting to the Emergency Department from April to September 2018 with CT-proven acute uncomplicated left-sided diverticulitis were screened for eligibility, and those meeting inclusion/exclusion criteria offered enrollment (Figure-1). Participants were randomized to receive either oral antibiotics or analgesia alone. Follow-up included daily phone calls for 7 days by a blinded nurse and clinic visits at 14-, 30-, and 60-days. Our primary endpoint was recruitment rate. Secondary outcomes included median visual analogue pain scores at 7 days and treatment failures (defined as persistent diverticulitis at 60-days, progression to complicated diverticulitis, hospital admission, and mortality). We determined a sample size of 40 patients would allow for an estimation of the recruitment rate to within a 14% margin of error with 95% confidence. Reporting of the pilot complied with the 2010-CONSORT extension for Pilot/Feasibility Trials.
RESULTS: Of the 37 patients screened, 24 met inclusion/exclusion criteria and 12 consented to participation. This represented a recruitment rate of 32%. Patients refusing participation (n=12) cited inability to attend clinic follow-ups, preconceived expectations of receiving antibiotics, and belief that antibiotics would expedite recovery. Seven patients were randomized to the antibiotic arm and 5 to the non-antibiotic arm. Median age of participants was 54 (30-70) years with an even gender distribution. Eleven patients (92%) completed the 7-day phone follow-up and expressed that they were satisfied and reassured by the phone calls. Ninety percent completed at least 30 days of follow-up, but only 44% adhered to all scheduled visits. Median follow-up was 45 days. One patient (8%) was lost to follow-up. There were no treatment failures in either group. Median pain scores at 7 days were 0 for both arms (0–2 for controls, 0–4 for experimental).
CONCLUSIONS: A large-scale RCT is feasible assuming a 32% recruitment rate and 92% retention rate. Recruitment and retention rates are likely to improve with (1) a more rigorous electronic platform to facilitate screening and appropriate implementation of inclusion/exclusion criteria, and (2) less stringent follow-up (i.e. a single visit at 30-days and phone follow-ups over the study year). Further investigation into non-antibiotic management of acute uncomplicated diverticulitis is warranted.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 95741
Program Number: P270
Presentation Session: Poster Session (Non CME)
Presentation Type: Poster