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A single-center, randomized, controlled trial comparing the effects of suture and ligation alone on postoperative complications in children with type ? esophageal atresia

A single-center randomized controlled trial to compare the effects of suture and ligation alone on postoperative complications in children with type ? esophageal atresia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058527
Enrollment
Unknown
Registered
2022-04-10
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital esophageal atresia

Interventions

Group A:Simple ligation of distal tracheoesophageal fistula
Group B:Suture distal tracheoesophageal fistula

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Received medical treatment in Beijing Children's Hospital Affiliated to Capital Medical University from November 2021 to November 2023, and was preliminarily diagnosed as type III esophageal atresia after clinical evaluation and imaging examination; 2. Age of admission <=7 days, birth weight 2-4kg; 3. The family members signed and agreed to join the study; 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Complicated with severe pneumonia, invasive respiratory support was required before surgery; 2. Complicated with severe heart malformations; 3. Laryngeal fissure; 4. With other life-threatening major malformations; 5. Fiberoptic bronchoscopy found that the proximal esophagus was connected to the trachea and formed a tracheoesophageal fistula; 6. Do not agree with thoracoscopic surgery; 7. Poor compliance with treatment or clinical research; 8. Refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
tracheoesophageal fistula recurrence;

Secondary

MeasureTime frame
anastomotic leakage;severe pneumonia;pneumothorax;gastroesophageal reflux;esophageal stricture;esophageal diverticulum;treatment costs;

Countries

China

Contacts

Public ContactHuang Jinshi

Beijing Children's Hospital, Capital Medical University

jsdr2002@126.com+86 10 59616459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026