Clinical Outcome of a Randomized Controlled Blinded Trial of Open Versus Laparoscopic Nissen Fundoplication in Infants and Children

Abstract

To compare the clinical outcome and endocrine response in children who were randomized to open or laparoscopic Nissen fundoplication using minimization. It is assumed that laparoscopic surgery is associated with less pain, quicker recovery and dampened endocrine response. Few randomized studies have been performed in children. Parents gave informed consent, and this study was approved and registered (ClinicalTrials.gov Identifier: NCT00231543). Anesthesia, postoperative analgesia and feeding were standardized. Parents and staff were blinded to allocation. Blood was taken for markers of endocrine response. Twenty open and 19 laparoscopic patients were comparable with respect to age, weight, neurological status, and presence of congenital anomalies. Median time to full feeds was 2 days in both groups (P = 0.85); hospital stay was 4.5 days in the open group versus 5.0 days in the laparoscopic group (P = 0.57). Pain was adequately managed in both groups and there was no difference in morphine requirements. Median follow-up was 22 (range 12-34) months. Dysphagia, recurrence and need for redo fundoplication were not different between groups; retching was higher after open surgery (56% vs. 6%; P = 0.003). Insulin levels decreased at 24 hours, and was 54% lower (P = 0.02) after laparoscopy. Cortisol was elevated immediately postoperative, but was 42% lower (P = 0.02) after laparoscopy. There was no difference in the postoperative analgesia requirements and recovery. Laparoscopy decreased insulin levels to a greater extent, but caused less of a response in cortisol. Early postoperative outcome confirmed equal efficacy, but fewer children with retching after laparoscopy.