Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial.

ABSTRACT:

Background

Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF.

Methods

Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained.

Clinicaltrials

gov: NCT01551134.

Results

SUBMITTER: Fyhn TJ 

PROVIDER: S-EPMC9839805 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature