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Cardiaplication: A Novel Antireflux Operation

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiaplication
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, fundoplication, cardiaplication, reflux

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cardiaplication

    Arm Description

    Outcomes

    Primary Outcome Measures

    Determine pH impedance probe results of Cardiaplication
    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

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

    Full Information

    First Posted
    December 20, 2013
    Last Updated
    October 20, 2017
    Sponsor
    Emory University
    Collaborators
    Children's Healthcare of Atlanta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02060500
    Brief Title
    Cardiaplication: A Novel Antireflux Operation
    Official Title
    Cardiaplication: A Prospective Observational Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University
    Collaborators
    Children's Healthcare of Atlanta

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease
    Keywords
    GERD, fundoplication, cardiaplication, reflux

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiaplication
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Cardiaplication
    Primary Outcome Measure Information:
    Title
    Determine pH impedance probe results of Cardiaplication
    Description
    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.
    Time Frame
    At 3 months post-operatively
    Secondary Outcome Measure Information:
    Title
    Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants
    Description
    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.
    Time Frame
    1 year post-op

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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