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

• Conditions: Post-Op Complication; Anastomosis; Complications
• Interventions: Other: observation of postoperative leak, stenosis, mortality

• Registration Number: NCT04504656
• Lead Sponsor: Assiut University

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 Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-07
• Last Update Posted: 2020-08-07
• Primary Completion: 2022-03-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	observation of postoperative leak, stenosis, mortality	open surgery
2	observation of postoperative leak, stenosis, mortality	minimally invasive surgery

Primary Outcome Measures

Name	Time	Method
Anastamotic leaks	2 years	Incidence of anastamotic leak which is identified clinically in both groups

Secondary Outcome Measures

Name	Time	Method
Mortality	2 years	Number of patient who die intraoperative and post operative in both groups
Anastamotic stricture	2 years	Incidence of symptomstic strictures which is identified by upper barium studies

Trial Locations

Locations (1)

Assiut University Children Hospitals; 🇪🇬 Assiut, Egypt