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Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia

NCT06208449 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-01-17

No results posted yet for this study

Summary

Thoracotomy repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient. thoracoscopy repair offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair. Robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair. However, there were no randomized controlled trials to verify the effectiveness of three procedures. The objection was to compare the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.

Conditions

  • Congenital Esophageal Atresia

Interventions

PROCEDURE

Robotic repair for EA

The paitents with EA were repaired by Da Vinci robot

PROCEDURE

Thoracoscopic repair for EA

The patients with EA were repaired by thoracoscopy

PROCEDURE

Thoracotomy repair for EA

The patients with EA were repaired by traditional open thoracotomy.

Sponsors & Collaborators

  • Guiyang Children's Hospital

    collaborator UNKNOWN

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Binzhou Medical University

    collaborator OTHER

  • Zunyi Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06208449 on ClinicalTrials.gov