Cardiaplication: A Novel Antireflux Operation
Cardiaplication: A Prospective Observational Trial
1 other identifier
interventional
8
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 24, 2017
October 1, 2017
2.7 years
December 20, 2013
October 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At 3 months post-operatively
Secondary Outcomes (1)
Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants
1 year post-op
Study Arms (1)
Cardiaplication
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.
You may not qualify if:
- Inability to obtain consent
- Surgeon preference
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Children's Healthcare of Atlantacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 20, 2013
First Posted
February 12, 2014
Study Start
June 1, 2012
Primary Completion
February 1, 2015
Study Completion
June 1, 2015
Last Updated
October 24, 2017
Record last verified: 2017-10