Fundoplication without esophagocrural sutures: Long-term follow-up of a randomized clinical trial

Abstract

IntroductionWe previously conducted a randomized trial that showed a lack of need for esophagocrural (EC) sutures during fundoplication when no esophageal dissection was performed. There was no difference in wrap herniation or other complications in the group without EC sutures at a median 1.5 years of follow-up. In this follow-up study, we aim to evaluate long-term symptom control and complication profiles in these patients. Methods106 patients were randomized and participated in the original trial. We were primarily concerned with identification of late complications and persistence of symptoms. Presently, we conducted a retrospective chart review and a telephone follow-up survey at a minimum of 6.5 years after fundoplication. Results100 patients were alive at late follow-up and 70% of caregivers responded to the telephone survey. 53% of patients were male; 76% were Caucasian. Of these children, 39 (56%) received four EC sutures, while 31 (44%) did not. Follow-up was conducted at a median of 8.7 years [IQR 8.2,9.7] post-fundoplication.Late wrap herniation was not demonstrated radiographically on chart review or caregiver report in either group. The rate of residual reflux symptoms, post-operative hospitalizations for pneumonia, failure to thrive (FTT), and brief resolved unexplained event (BRUE) were also similar between groups. ConclusionLong-term follow-up in children who underwent fundoplication without esophagocrural sutures demonstrates no difference in symptom management or subsequent hospitalizations at a minimum of 6.5-year follow-up. Level of evidenceII (follow-up of a randomized controlled trial)