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IRCT20210518051337N1 IRCT 2021-12-27 Tabriz University of Medical Sciences Comparison of delayed primary esophageal repair in patients with long gap esophageal atresia with primary esophageal replacement. Comparison of delayed primary esophageal anastomosis in patients with long gap esophageal atresia with primary esophageal replacement by gastric pull up sugery. 2021-12-06 anticipated 20 Complete https://irct.ir/trial/56519 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among neonates with esophageal atresia without fistula who have the inclusion criterias to enter the study, all patients with parental consent are admitted to the study in non-randomly manner. Then random division is done between study groups. In this study, a simple random allocation method using the RandList 1.2 function of Excel software is used as a tool for randomization. 1 group of delayed treatment and 2 group of neonatal surgery.In the randomization process for allocation concealment. 2 esophgeal atresia without fistula. Intervention 1: Intervention group: delayed repair by primary anastomosis The first group received delayed intervention.the newborns with type A LGEA, the first surgical intervention was placement of gastrostomy tube through an open surgery. A tube was used as the gastrostomy and in order to prevent aspiration, proximal pouch of the esophagus was repeatedly suctioned via a nasogastric or orogastric tube. Twenty days after the gastrotomy, an esophagoscope or bogie was inserted through the proximal pouch of esophagus and a bougie was inserted into the distal pouch of esophagus via gasterostomy, afterwards, the gap length between the proximal and distal esophageal pouch was measured by taking a radiograph. If the gap length was less than 2 cm, a primary esophageal anastomosis was performed immediately through right posterolateral thoracotomy. However, if the gap length was more than 2 cm, watchful waiting would have been continued and evaluation of the gap length was delayed for 20-30 days later. Esophageal reconstruction was delayed until the proper gap length was achieved. In first 3 months after birth, if there were any evidences of development and the gap length decrease to less than 2 cm (or less than the length of two vertebral bodies), delayed esophageal anastomosis was performed. Outcomes of this procedure was then evaluated considering the side effects such as pulmonary infections and sepsis occurring during the watchful waiting. The watchful waiting of the infant was done for 4 months after the esophageal reconstruction. Intervention 2: Control group: Gastric pull-up surgery in the neonatal period. The second group received primary intervention. In this group, in order to replace a section of underdeveloped esophagus with reconstructed stomach tissue, gastric pull up surgery was performed by the midline lapatomy and release of gastric tissue in the base of right gastric and gastroepipoloic arteries and gastric pull-up through the hiatus diapgragm and anastomosis through the right sided neck or right thorax cavity to the proximal pouch of esophgus. After the surgery, parenteral feeding was done until the patient was able to tolerate normal oral diet. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public nazila Hasan zadeh Ghavifekr
Gholshar- Ghole yakh st. 22
Tabriz Iran (Islamic Republic of) 5167858549 +98 41 3385 1683 nazila.hasanzadeh@gmail.com Tabriz University of Medical Sciences scientific Saeid AslanAbadi
sheshgelan st. Tabriz childrens' Hospital
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2250 aslanabadis@hotmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Long gap congenital esophageal atresia no limit 5 days Both presence of gastric air in postnatal x-ray prior esophagostomy before enterance to study suspicious upper pouch fistula Other severe congenital anomalies with unstable general condition Q39.1 Atresia of esophagus without tracheo-esophageal fistula Treatment - Surgery Treatment - Surgery Intervention group: delayed repair by primary anastomosis The first group received delayed intervention.the newborns with type A LGEA, the first surgical intervention was placement of gastrostomy tube through an open surgery. A tube was used as the gastrostomy and in order to prevent aspiration, proximal pouch of the esophagus was repeatedly suctioned via a nasogastric or orogastric tube. Twenty days after the gastrotomy, an esophagoscope or bogie was inserted through the proximal pouch of esophagus and a bougie was inserted into the distal pouch of esophagus via gasterostomy, afterwards, the gap length between the proximal and distal esophageal pouch was measured by taking a radiograph. If the gap length was less than 2 cm, a primary esophageal anastomosis was performed immediately through right posterolateral thoracotomy. However, if the gap length was more than 2 cm, watchful waiting would have been continued and evaluation of the gap length was delayed for 20-30 days later. Esophageal reconstruction was delayed until the proper gap length was achieved. In first 3 months after birth, if there were any evidences of development and the gap length decrease to less than 2 cm (or less than the length of two vertebral bodies), delayed esophageal anastomosis was performed. Outcomes of this procedure was then evaluated considering the side effects such as pulmonary infections and sepsis occurring during the watchful waiting. The watchful waiting of the infant was done for 4 months after the esophageal reconstruction. Control group: Gastric pull-up surgery in the neonatal period. The second group received primary intervention. In this group, in order to replace a section of underdeveloped esophagus with reconstructed stomach tissue, gastric pull up surgery was performed by the midline lapatomy and release of gastric tissue in the base of right gastric and gastroepipoloic arteries and gastric pull-up through the hiatus diapgragm and anastomosis through the right sided neck or right thorax cavity to the proximal pouch of esophgus. After the surgery, parenteral feeding was done until the patient was able to tolerate normal oral diet. Decrease of the gap between upper and lower pouch os esophagus. Timepoint: initially two weeks after birth and then continuously every 20 days. Method of measurement: measurement of distance between upper and lower pouch of esophagus with opaque bogie under anesthesia and evaluation of therapeutic result and complications with checklist. Short term and long term complicayions of surgery. Timepoint: during operation, inthe post operation period, 2 month later, 4 month later. Method of measurement: clinical and radiologic signs of complications such as anastomosis leak, pneumonia, sepsis, stricture and reflux. The ability to save and reconstruct the own esophagus of patient. Timepoint: n the operative procedure. Method of measurement: the operation Feasibility. Tabriz University of Medical Sciences Approved 2021-11-29 Research Ethics Committees of Tabriz University of Medical Sciences Evaluated by: Ap Tabriz University of Medical Sciences., Golgasht St., Azadi St Tabriz East Azarbaijan Iran (Islamic Republic of)