ABSTRACT
Introduction: Refusal to follow-up may affect the course of the ongoing randomized controlled trials (RCT). The aim of this study was to evaluate the impact of COVID-19 pandemic on follow-up refusal rate in an ongoing surgical RCT. Method(s): The study group comprised 107 participants enrolled in an ongoing surgical RCT designed to compare mass with layered closure of transverse abdominal incisions with respect to incisional hernias. Study group was divided into patients who were scheduled to have follow-up visit before (pre-COVID) and after (post-COVID) April 1st 2020. Follow-up refusal rate was compared in both groups. Result(s): Follow-up refusal rate in pre-COVID group was 18.52% (10 out of 55 patients), whereas in post-COVID group it was 50% (26 out of 52 patients;p=0.0004). Median value of age during scheduled follow-up day was 60 years and the distance from patients place of living was 151 km. The pandemic particularly increased refusal rate in patients living >151km from hospital (p <0.0001), patients older than 60 years (p=0.006), and in female patients (p=0.005). Conclusion(s): COVID-19 pandemic leads to remarkable increase in follow-up refusal rate among participants enrolled in RCT's, particularly in females, older patients, and in those living in a long-distance from the centre. Copyright © 2022