Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children

Study Overview
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Brief Summary
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a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children

Detailed Description
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Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.

Official Title
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Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children

Conditions
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Post-Op Complication, Anastomosis; Complications

Intervention / Treatment
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* Other: observation of postoperative leak, stenosis, mortality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children undergoing oesophageal replacement aged one to 18 years. Due to long gap esophageal atresia caustic ingestion congenital esophageal stenosis or strictures Exclusion Criteria: patient who underwent previous esophageal replacement operations.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>open surgery | Other: observation of postoperative leak, stenosis, mortality<br>* detect complications in both groups<br>|
| 2<br>minimally invasive surgery | Other: observation of postoperative leak, stenosis, mortality<br>* detect complications in both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastamotic leaks | Incidence of anastamotic leak which is identified clinically in both groups | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastamotic stricture | Incidence of symptomstic strictures which is identified by upper barium studies | 2 years | 
| Mortality | Number of patient who die intraoperative and post operative in both groups | 2 years |