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Clinical Trials/NCT04504656
NCT04504656
Unknown
Not Applicable

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

Assiut University1 site in 1 country20 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Op Complication
Sponsor
Assiut University
Enrollment
20
Locations
1
Primary Endpoint
Anastamotic leaks
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
October 1, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

A maher

Assistant lecturer of surgery

Assiut University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anastamotic leaks

Time Frame: 2 years

Incidence of anastamotic leak which is identified clinically in both groups

Secondary Outcomes

  • Mortality(2 years)
  • Anastamotic stricture(2 years)

Study Sites (1)

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