Clinical Trial: Dumping Syndrome After Operation of Esophageal Atresia Type III

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: University Hospital, Lille

Current Primary Outcome:

  • Early hyperglycemia during Oral Glucose Tolerance Test (OGTT) [ Time Frame: up to 240 min ]
    Hypoglycemia : glycemia < 0,6 g/L
  • 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.
  • 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
  • Post-surgery complications [ Time Frame: 1 day ]
    anastomotic leakage, mediastinitis


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: August 14, 2015
Date Started: June 14, 2011
Date Completion: June 2018
Last Updated: May 17, 2017
Last Verified: May 2017