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NCT Number: NCT02525705

Dumping Syndrome After Operation of Esophageal Atresia Type III

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.

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Key information

Conditions

Oesophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Dumping Syndrome Esophageal Atresia Esophageal Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postgastrectomy Syndromes Postoperative Complications Stomach Diseases

Age range

Up to 14 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pellegrin - Hôpital d'Enfants,, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Early hyperglycemia during Oral Glucose Tolerance Test (OGTT)

    Time frame: up to 240 min

    Hypoglycemia : glycemia < 0,6 g/L

  2. Late hypoglycemia during OGTT

    Time frame: up to 240 min

    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

Secondary outcomes

  1. Clinical signs presenting consequently to OGTT

    Time frame: continuous monitoring during 240 minutes

    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

  2. Associated pathologies

    Time frame: 1 day

    neurologic, extremities, ribbs and vertebrales, genito-urinary, renal, cardiovascular, ano-rectal, microgastria and others. Syndromic associations are also noted, as VACTERL and charge syndroms.

  3. Surgery details

    Time frame: 1 day

    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

  4. Post-surgery complications

    Time frame: 1 day

    anastomotic leakage, mediastinitis

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: DUMPING

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2015
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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