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Clinical outcome of a randomized controlled blinded trial of open versus laparoscopic Nissen fundoplication in infants and children.

Author(s): McHoney M, Wade AM, Eaton S, Howard RF, Kiely EM, Drake DP, Curry JI, Pierro A

Affiliation(s): Department of Surgery, Royal Hospital for Sick Children, Edinburgh, UK.

Publication date & source: 2011-08, Ann Surg., 254(2):209-16.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To compare the clinical outcome and endocrine response in children who were randomized to open or laparoscopic Nissen fundoplication using minimization. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Page last updated: 2011-12-09

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