Cardiaplication: A Novel Antireflux Operation
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiaplication
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, fundoplication, cardiaplication, reflux
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
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
NCT ID
NCT02060500
First Posted
December 20, 2013
Last Updated
October 20, 2017
Sponsor
Emory University
Collaborators
Children's Healthcare of Atlanta
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
Learn more about this trial
Cardiaplication: A Novel Antireflux Operation
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