Overview

This trial is active, not recruiting.

Condition gastroesophageal reflux disease
Treatment cardiaplication
Sponsor Emory University
Collaborator Children's Healthcare of Atlanta
Start date June 2012
End date February 2015
Trial size 20 participants
Trial identifier NCT02060500, IRB00056015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cardiaplication

Primary Outcomes

Measure
Determine pH impedance probe results of Cardiaplication
time frame: At 3 months post-operatively

Secondary Outcomes

Measure
Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants
time frame: 1 year post-op

Eligibility Criteria

Male or female participants up to 12 months old.

Inclusion Criteria: - Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD. Exclusion Criteria: - Inability to obtain consent - Surgeon preference

Additional Information

Official title Cardiaplication: A Prospective Observational Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.