NCT02060500

Cardiaplication: A Novel Antireflux Operation

Cardiaplication: A Prospective Observational Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Cardiaplication

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2014-02-12
• Last updated: 2017-10-24