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Cardiaplication: A Novel Antireflux Operation

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ClinicalTrials.gov Identifier: NCT02060500
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Mark L. Wulkan, M.D., 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Procedure: Cardiaplication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiaplication: A Prospective Observational Trial
Study Start Date : June 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Cardiaplication Procedure: Cardiaplication



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Mark L. Wulkan, M.D., Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02060500     History of Changes
Other Study ID Numbers: IRB00056015
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Mark L. Wulkan, M.D., Emory University:
GERD
fundoplication
cardiaplication
reflux

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases