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

Post-Op Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504656
• Other study ID #: Esophageal replacement
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Ahmed Maher, Msc.
• Phone: 01026338229
• Email: ahmedmaherali31[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

All children undergoing oesophageal replacement aged one to 18 years. Due to

1. long gap esophageal atresia

2. caustic ingestion

3. congenital esophageal stenosis or strictures

Exclusion Criteria:

• patient who underwent previous esophageal replacement operations.

Related Conditions & MeSH terms

• Anastomosis; Complications
• Post-Op Complication
• Postoperative Complications

Intervention

Other:
• observation of postoperative leak, stenosis, mortality
detect complications in both groups

Locations

Country	Name	City	State
Egypt	Assiut University Children Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastamotic leaks	Incidence of anastamotic leak which is identified clinically in both groups	2 years
Secondary	Anastamotic stricture	Incidence of symptomstic strictures which is identified by upper barium studies	2 years
Secondary	Mortality	Number of patient who die intraoperative and post operative in both groups	2 years