Dumping Syndrome After Operation of Esophageal Atresia Type III
NCT ID: NCT02525705
Last Updated: 2019-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2011-06-14
2018-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasability and Interest of Screening for Infantile Pompe's Diseases at Birth
NCT02904395
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
NCT03322345
Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis
NCT04555200
Influence of Airway Clearance Techniques on GOR in Infants
NCT03346174
Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
NCT04957667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Every EA patients
This is a one group interventional study. Every patient is included in the same arm.
Oral Glucose
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral Glucose
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
14 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Lille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laurent Michaud, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-A00217-32
Identifier Type: OTHER
Identifier Source: secondary_id
2009_42/1004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.