Cardiaplication: A Novel Antireflux Operation

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: Cardiaplication

• Registration Number: NCT02060500
• Lead Sponsor: Emory University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.

Read More

Exclusion Criteria

• Inability to obtain consent
• Surgeon preference

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiaplication	Cardiaplication	-

Primary Outcome Measures

Name	Time	Method
Determine pH impedance probe results of Cardiaplication	At 3 months post-operatively	We will perform a pH impedance probe on all patients at 3 months post-op (+/- 30 days). We are looking for a statistically significant improvement in per-cent time the pH is \<= 4.

Secondary Outcome Measures

Name	Time	Method
Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants	1 year post-op	Radiographs at 1 year will be compared to post-op chest x-ray to determine vertical length between clips placed intra-operatively at the GE junction and on the diaphragmatic crus.