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

NCT ID: NCT04504656

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-10-01

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.

Conditions

Post-Op Complication; Anastomosis; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

open surgery

observation of postoperative leak, stenosis, mortality

Intervention Type: OTHER

detect complications in both groups

2

minimally invasive surgery

observation of postoperative leak, stenosis, mortality

Intervention Type: OTHER

detect complications in both groups

Interventions

observation of postoperative leak, stenosis, mortality

detect complications in both groups

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

A maher

Assistant lecturer of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Eltayeb, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University Children Hospitals

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Maher, Msc.

Role: CONTACT

ahmedmaherali31@gmail.com

01026338229

Mahmoud Mohamed Mostafa, MD

Role: CONTACT

mmostafa@aun.edu.eg

01005010897

Facility Contacts

Mohamed Abdel-Kadir Othman Ahmed, MD

Role: primary

osman@med.aun.edu.eg

01062226639

Other Identifiers

Esophageal replacement

Identifier Type: -

Identifier Source: org_study_id