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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00217-32 | Other Identifier | ID-RCB number, ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Every EA patients | Experimental | This is a one group interventional study. Every patient is included in the same arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucose | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Michaud, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin - Hôpital d'Enfants, | Bordeaux | France | ||||
| CHU Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32443041 | Result | Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651. | |
| 11527163 |
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| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| D004377 | Dumping Syndrome |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| 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 |
| Grenoble |
| France |
| Hôpital Jeanne de Flandre CHRU | Lille | France |
| Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques | Lyon | France |
| CHU Nantes | Nantes | France |
| AP-HP, Hôpital Necker | Paris | France |
| Hôpital Robert Debré ,Service de chirurgie viscérale et urologique | Paris | France |
| CHU Rouen | Rouen | France |
| CHU Strasbourg | Strasbourg | France |
| CHU Toulouse, Hôpital Enfant | Toulouse | France |
| Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5. doi: 10.1007/s003830000525. |
| 8890072 | Result | Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40. doi: 10.1097/00005176-199610000-00006. |
| 12948306 | Result | Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15. doi: 10.1515/jpem.2003.16.6.907. |
| 11743518 | Result | Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. doi: 10.1067/mpd.2001.119169. |
| 20385264 | Result | Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016. |
| 17638154 | Result | Holschneider P, Dubbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75. doi: 10.1055/s-2007-965087. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011178 | Postgastrectomy Syndromes |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |