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

NCT04504656 — Unknown, 20 participants, Assiut University

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RegistryNCT04504656
StatusUnknown
Study typeObservational
Enrollment20 (Estimated)
SponsorAssiut University (Other)
ConditionsPost-Op Complication, Anastomosis; Complications
Interventionsobservation of postoperative leak, stenosis, mortality (Other)
Datesstart 2020-03-01, primary completion 2022-03-01 (estimated), completion 2022-10-01 (estimated), first posted 2020-08-07, last updated 2020-08-07
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Post-Op Complication All trials for Anastomosis; Complications All trials of observation of postoperative leak, stenosis, mortality

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
1Other: observation of postoperative leak, stenosis, mortalityopen surgery
2Other: observation of postoperative leak, stenosis, mortalityminimally invasive surgery
  • observation of postoperative leak, stenosis, mortality (Other): detect complications in both groups

+Outcome measures

Primary outcomes

  • Anastamotic leaks [2 years]: Incidence of anastamotic leak which is identified clinically in both groups

Secondary outcomes

  • Anastamotic stricture [2 years]: Incidence of symptomstic strictures which is identified by upper barium studies
  • Mortality [2 years]: Number of patient who die intraoperative and post operative in both groups

+Eligibility

Sex: All, ages: any to 18 Years

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.

+Locations (1)

FacilityCityCountryStatus
Assiut University Children HospitalsAsyutEgyptRecruiting

+Investigators