Status:
COMPLETED
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
Lead Sponsor:
Johns Hopkins University
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
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.
Detailed Description
Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurolog...
Eligibility Criteria
Inclusion
- clinical or radiographic diagnosis of gastroesophageal reflux
- age less than 2 years (24 months) at the time of surgery
Exclusion
- 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)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00382850
Start Date
November 1 2005
End Date
November 30 2010
Last Update
August 1 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287