Dumping Syndrome After Operation of Esophageal Atresia Type III (NCT02525705) | Clinical Trial Compass
CompletedNot Applicable
Dumping Syndrome After Operation of Esophageal Atresia Type III
France42 participantsStarted 2011-06-14
Plain-language summary
The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.
Who can participate
Age range
14 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* New born less than 3.5 months or age corrected for premature new born
* Weight ≥ 4, 150 kg
* Esophageal atresia (EA) type III or IV
* EA Surgery between May 2013 and June 2016
* Stop of prokinetic treatment \> 72 h before OGTT
* Information and consent of parents
* Patients with health insurance
Exclusion Criteria:
* Age \> 3.5 months
* Weight \< 4.150 kg
* Other types of EA
* Dumping syndrom from other origin: microgastria, dysautonomia, small intestine surgery
* Other pathology that can modify glycemia: neonatal diabete, hyperinsulinism
* Treatment that can modify gastric motility: domperidone, erythromycin, baclofen that hasn't been stopped in the 72h before OGTT
* Absence of consent
* Patient judiciary protected
* Simultaneous participation to another clinical trial
* No health insurance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)