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Procedure
Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
N/A
Waitlist Available
Led By Paul M Colombani, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Gastroesophageal Reflux Disease
- Acid Reflux
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
length of time to tolerating full feeds prior to discharge
postoperative length of stay
postoperative narcotic pain medication requirements
Secondary study objectives
death
intraoperative complication rates
need for continued medical therapy for GER
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: laparoscopic nissen fundoplicationActive Control1 Intervention
use of laparoscope to do repair
Group II: open nissen fundoplicationActive Control1 Intervention
open repair through surgical midline incision
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,563 Total Patients Enrolled
Paul M Colombani, MDPrincipal InvestigatorJohns Hopkins University