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Cardiaplication: A Novel Antireflux Operation

Cardiaplication: A Prospective Observational Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060500
Enrollment
8
Registered
2014-02-12
Start date
2012-06-30
Completion date
2015-06-30
Last updated
2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD, fundoplication, cardiaplication, reflux

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.

Interventions

PROCEDURECardiaplication

Sponsors

Children's Healthcare of Atlanta
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine pH impedance probe results of CardiaplicationAt 3 months post-operativelyWe 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

MeasureTime frameDescription
Validate elongation of the intra-abdominal esophagus as a mechanism for outgrowing GERD in infants1 year post-opRadiographs 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026