Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux

In brief

The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.

Key facts

Study ID

NCT00382850

Run by

Johns Hopkins University

People needed

68

Starts

2005-11-01

Expected to finish

2010-11-30

Last updated by the study team

2018-08-01

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinical or radiographic diagnosis of gastroesophageal reflux
• age less than 2 years (24 months) at the time of surgery

You may not qualify if…

• prior fundoplication procedure
• concomitant need for an intraabdominal procedure (except gastrostomy tube placement)
• esophageal dysmotility
• hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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