Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-30 @ 7:19 PM
Study NCT ID:
NCT04504656
Status:
UNKNOWN
Last Update Posted:
2020-08-07
First Post:
2020-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: