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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Notify MeKey information
Conditions
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
Primary outcomes
-
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
-
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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