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

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

Study Overview

• Status: Unknown
• Conditions: Post-Op Complication; Anastomosis; Complications
• Intervention / Treatment: Other: observation of postoperative leak, stenosis, mortality

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ahmed Maher, Msc.; Phone Number: 01026338229; Email: ahmedmaherali31@gmail.com
• Study Contact Backup: Name: Mahmoud Mohamed Mostafa, MD; Phone Number: 01005010897; Email: mmostafa@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University Children Hospitals
    • Contact: Mohamed Abdel-Kadir Othman Ahmed, MD; Phone Number: 01062226639; Email: osman@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children up to 18 years

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; open surgery	Other: observation of postoperative leak, stenosis, mortality; detect complications in both groups
2; minimally invasive surgery	Other: observation of postoperative leak, stenosis, mortality; detect complications in both groups

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed Eltayeb, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Esophageal replacement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No