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OpenTrials
Completed

NCT Number: NCT02060500

Cardiaplication: A Novel Antireflux Operation

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.

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiaplication

Procedure

Primary outcomes

  1. Determine pH impedance probe results of Cardiaplication

    Time frame: 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 outcomes

  1. Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Children's Healthcare of Atlanta

Registry information

Official study title

Cardiaplication: A Prospective Observational Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2014
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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