Dumping Syndrome After Operation of Esophageal Atresia Type III

University Hospital, Lille42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Oesophageal Atresia Dumping Syndrome

Interventions

Oral GlucoseBIOLOGICAL

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.

Eligibility

Sex: ALLMax age: 14 Weeks

Medical Language ↔ Plain English

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

Locations (10)

Hôpital Pellegrin - Hôpital d'Enfants,

Bordeaux, France

CHU Grenoble

Grenoble, France

Hôpital Jeanne de Flandre CHRU

Lille, France

Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques

Lyon, France

Outcomes

Primary Outcomes

Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)

Hypoglycemia : glycemia \< 0,6 g/L

Time frame: 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

Time frame: up to 240 min

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 1 day

Post-surgery complications

anastomotic leakage, mediastinitis

Time frame: 1 day

Data from ClinicalTrials.gov

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