Preoperative nutritional support in children with Hirschsprung disease: a prospective multicenter open-label randomized controlled trial

Preoperative undernutrition is prevalent among children with Hirschsprung disease (HSCR). To evaluate whether preoperative nutritional support reduces the incidence of postoperative HSCR-associated enterocolitis (HAEC), we conducted a prospective, multicenter, open-label randomized controlled trial. The trial was initiated on January 1, 2021 and completed on October 31, 2022. It was carried out across seven tertiary hospitals in China. A total of 110 patients admitted for pull-through surgery for HSCR were enrolled. Eligible participants were randomly assigned 1:1 via a centralized web-based randomization system ( www.cbdps.com ), which generated the allocation sequence. Specifically, 55 patients were allocated to the preoperative nutritional support (PNS) group and 55 to the standard medical care (SMC) group. Surgeons and patients were not blinded to group assignment. The primary outcome was the incidence of HAEC at 3 months after surgery. At 3 months postoperatively, the incidence of HAEC in the PNS group was significantly lower compared to the SMC group. Specifically, the HAEC incidence was 7.27% (4/55) for the PNS group versus 29.09% (16/55) for the SMC group. This resulted in an absolute risk reduction of 21.82% (95% confidence interval: -35.64% to -7.99%; p = 0.003). No adverse events were documented. These results demonstrate that preoperative nutritional support substantially reduces early HAEC incidence in pediatric HSCR patients following pull-through surgery. Trial Registration: ClinicalTrials.gov NCT04598841.