Cardiaplication: A Novel Antireflux Operation

Emory University

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: Cardiaplication

Study type: Interventional

Funder types: Other

Identifiers

NCT02060500

IRB00056015

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Cardiaplication

Experimental group

Treatment:

Procedure: Cardiaplication