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Cardiaplication: A Novel Antireflux Operation

NCT02060500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-10-24

No results posted yet for this study

Summary

Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

PROCEDURE

Cardiaplication

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Emory University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-02-28
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02060500 on ClinicalTrials.gov