- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060500
Cardiaplication: A Novel Antireflux Operation
October 20, 2017 updated by: Mark L. Wulkan, M.D., Emory University
Cardiaplication: A Prospective Observational Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardiaplication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 3 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
February 10, 2014
First Posted (Estimate)
February 12, 2014
Study Record Updates
Last Update Posted (Actual)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00056015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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