Dumping Syndrome After Operation of Esophageal Atresia Type III

Study Overview
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Brief Summary
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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.

Detailed Description
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Consecutive patients with type III and IV oesophageal atresia that are born in 8 different centers in France and Sydney (Australia) are included in the study, if willing. As soon as they weigh more than 4.150kg and if they are still younger than 3.5 months, an Oral Glucose Tolerance Test (OGTT) is performed. Glycemia and insulinemia are monitored every 30 minutes from intake to 240 minutes. Clinical signs that are presented are noted. If early hyperglycemia or late hypoglycemia are biologically or clinically observed, ascarbose treatment is initiated.

Official Title
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Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III

Conditions
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Oesophageal Atresia, Dumping Syndrome

Intervention / Treatment
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* Biological: Oral Glucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Every EA patients<br>This is a one group interventional study. Every patient is included in the same arm. | Biological: Oral Glucose<br>* 1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early hyperglycemia during Oral Glucose Tolerance Test (OGTT) | Hypoglycemia : glycemia < 0,6 g/L | up to 240 min | 
| Late hypoglycemia during OGTT | Hyperglycemia : > 1,8g/L from H0 to 30 min after oral intake, > 1.7 between 1 and 2 h ours, > 1.4 between 2 and 3 h , > 1, 26 after 3 h | up to 240 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs presenting consequently to OGTT | frequent clinical reflux (>3/day), suspicion of esophagitis (pain while eating), colics, post-prandial diarrhea (liquid stools in the first hour after meal), abdominal pain, flatulence, pallor, hypotonia, agitation, convulsions, somnolence, sweat | continuous monitoring during 240 minutes | 
| Associated pathologies | neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms. | 1 day | 
| Surgery details | postponed anastomosis, difficulty or tension in the suture, colic or gastric plasty if needed, tracheoscopy realisation, visualisation or damage of the X nerve, observation of a microgastria during surgery, other relevant informations of surgery | 1 day | 
| Post-surgery complications | anastomotic leakage, mediastinitis | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants, oesophageal atresia, dumping syndrome, prevalence, Type III and IV, Oral glucose tolerance test, early hyperglycemia, late hypoglycemia