Skip to content

Comparison of two different surgeries for windpipe-foodpipe abnormalities

Thoracoscopic repair (TR) versus Conventional open repair (COR) for Tracheoesophageal fistula - Esophageal atresia(TEF-EA): A pilot randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025456
Enrollment
60
Registered
2020-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Q391- Atresia of esophagus with tracheo-esophageal fistula

Interventions

Intervention1: Thoracoscopic repair of TEF: The patient will be placed in a semi-prone position with the right side elevated by 450. A 5-mm trocar will be inserted approximately 1 cm below the angle o

Sponsors

Dr Manasa Reddy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newborns with trachea oesophageal fistula

Exclusion criteria

Exclusion criteria: Weight Corrected gestational age Corrected gestational age > 44 weeks or post-natal age > 28 days (whichever is later). TEF types other than TEF-EA (e.g. pure esophageal atresia and H-type tracheoesophageal fistula). Presence of major associated congenital anomalies (e.g. duodenal atresia, anorectal malformations, etc.) requiring second surgery in the same setting or within 1-2 days. Major symptomatic cardiac anomalies defined as the presence of cyanosis, murmur, and difference in pre- and post-ductal saturation. Need for high frequency oscillatory ventilation (HFOV) in the pre-operative period. Prior attempted surgical repair

Design outcomes

Primary

MeasureTime frame
Incidence of post-operative complications(anastomotic leak, stricture) in TR vs COR of TEF-EATimepoint: 6 months

Secondary

MeasureTime frame
All cause mortalityTimepoint: 28 days

Countries

India

Contacts

Public ContactV Manasa Reddy

PGIMER

nitinjamespeters@yahoo.com8427692770

Outcome results

None listed

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