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OUTCOME OF TRACHEO-ESOPHAGEAL FISTULA REPAIR SURGERY WITHOUT USING TRANSANASTOMOTIC FEEDING TUBE

Clinical outcome of tracheoesophageal fistula repair with or without the use of trans-anastomotic feeding tube: a pilot randomised control trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052527
Enrollment
60
Registered
2023-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: avoid TAFT tube: From intraoperative period till discharge from hospital Control Intervention1: TAFT: using TAFT in repair of Tracheo-esophageal fistula placed intraoperatively

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Weight > 1.8KG 2. SNAPPE II Score < 7

Exclusion criteria

Exclusion criteria: 1. Major symptomatic cardiac anomalies are defined as the presence of cyanosis, murmur, and difference in pre and post-ductal saturation. (Tetralogy of Fallot with Pulmonary stenosis, Single ventricle, Tricuspid atresia and Truncus arteriosus) 2. Parents not willing to participate in the study 3. Babies who were operated outside and referred for complications • Babies who were diverted (oesophagostomy + gastrostomy) on the table in case of long gap ( >3 vertebral bodies) • Presence of major associated congenital anomalies (e.g., duodenal atresia, anorectal malformations, etc.) requiring second surgery in the same setting or within the immediate postoperative period. • TEF types other than EA/TEF (e.g., pure oesophageal atresia and H-type tracheoesophageal fistula)

Design outcomes

Primary

MeasureTime frame
To compare the rate of an anastomotic leak following primary repair of EA/TEF with and without TAFTTimepoint: post operative period : follow up upto 6 months after surgery.

Secondary

MeasureTime frame
All-cause mortality at 30 daysTimepoint: 30 days;Anastomotic strictureTimepoint: 2 weeks, 1 month, 3 months, 6 months;Incidence of BRUE/ALTETimepoint: 2 weeks, 1 month, 3 months, 6 months;Incidence of GERDTimepoint: 2 weeks, 1 month, 3 months, 6 months;Somatic growthTimepoint: 2 weeks, 1 month, 3 months, 6 months;Time to reach full feedTimepoint: post operative period;Time to start feedTimepoint: post operative period

Countries

India

Contacts

Public ContactDr Nitin James Peters

Post Graduate Institute of Medical Research and Education

nitinjamespeters@yahoo.com9878604586

Outcome results

None listed

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