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

Phase 3

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/05/052527

Brief Summary

**The patients being operated on for tracheo-oesophagal fistula and undergoing primary oesophagal anastomosis will be randomised into 2 groups.**

**1. with TAFT- 6 Fr Nasogastric tube will be placed across the oesophagal anastomosis intraoperatively and will be used for giving tube feeds and removed once the child is stable postoperatively and is tolerating full oral feeds**

**2. without TAFT- NO Nasogastric tube will be placed across the oesophagal anastomosis intraoperatively and the child will be started on oral feeds in the postoperative period.**

**Both the groups will be followed up at various time points such as at discharge, 2 weeks, 1 month, 3 months and 6 months with respect to outcome measures.**

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-13
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Weight > 1.8KG 2.
• SNAPPE II Score < 7.

Exclusion Criteria

• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to start feed	post operative period
Anastomotic stricture	2 weeks, 1 month, 3 months, 6 months
Time to reach full feed	post operative period
Incidence of BRUE/ALTE	2 weeks, 1 month, 3 months, 6 months
Incidence of GERD	2 weeks, 1 month, 3 months, 6 months
Somatic growth	2 weeks, 1 month, 3 months, 6 months
All-cause mortality at 30 days	30 days

Trial Locations

Locations (1)

APC, PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

APC, PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Ramyasree bade

Principal investigator

8438373531

ramyabade@gmail.com