Cardiaplication: A Novel Antireflux Operation
This trial is active, not recruiting.
|Condition||gastroesophageal reflux disease|
|Collaborator||Children's Healthcare of Atlanta|
|Start date||June 2012|
|End date||February 2015|
|Trial size||20 participants|
|Trial identifier||NCT02060500, IRB00056015|
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.
|Intervention model||single group assignment|
Determine pH impedance probe results of Cardiaplication
time frame: At 3 months post-operatively
Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants
time frame: 1 year post-op
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
|Official title||Cardiaplication: A Prospective Observational Trial|
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