The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
The subjects will be included at time of the first dilation for an anastomotic stricture. Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms). Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre. OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia. Parents will be asked to bring the empty caps which will be counted for assessment of compliance.
Apple Sauce 5 mL+ 1 mL saline
number of dilations needed after randomization (beginning of treatment)
number of dilations needed after randomization (beginning of treatment)
Time frame: 12 months
Number of patients needing dilation after randomization (beginning of treatment)
Number of patients needing dilation after randomization (beginning of treatment)
Time frame: 12 months
Number of patients needing more than 3 dilations after randomization
Number of patients needing more than 3 dilations after randomization
Time frame: 12 months
Mean time to further dilation
Mean time to further dilation
Time frame: 12 months
Number of patients treated with an adjuvant therapy
Number of patients treated with an adjuvant therapy
Time frame: 12 months
Ability to tolerate normal food for age
Ability to tolerate normal food for age
Time frame: 12 months
Dysphagia score
Dysphagia score
Time frame: 12 months
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
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Time frame: 12 months
Side effects/Adverse events
Side effects/Adverse events
Time frame: 12 months