| CTRI Number |
CTRI/2023/05/052527 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
OUTCOME OF TRACHEO-ESOPHAGEAL FISTULA REPAIR SURGERY WITHOUT USING TRANSANASTOMOTIC FEEDING TUBE |
|
Scientific Title of Study
|
Clinical outcome of tracheoesophageal fistula repair with or without the use of trans-anastomotic feeding tube: a pilot randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin James Peters |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Research and Education |
| Address |
room no 5417, department of Paediatric surgery,5 floor D block, Advanced paediatric centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878604586 |
| Fax |
|
| Email |
nitinjamespeters@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin James Peters |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Research and Education |
| Address |
room no 5417, department of Paediatric surgery,5 floor D block, Advanced paediatric centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878604586 |
| Fax |
|
| Email |
nitinjamespeters@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin James Peters |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Research and Education |
| Address |
room no 5417, department of Paediatric surgery,5 floor D block, Advanced paediatric centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878604586 |
| Fax |
|
| Email |
nitinjamespeters@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ramyasree bade |
APC, PGIMER |
OPERATION THEATRE, 6 FLOOR, A BLOCK, ADVANCED PAEDIATRIC CENTER, PGIMER
Chandigarh
CHANDIGARH |
8438373531
ramyabade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
avoid TAFT tube |
From intraoperative period till discharge from hospital |
| Comparator Agent |
TAFT |
using TAFT in repair of Tracheo-esophageal fistula placed intraoperatively |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
1. Weight > 1.8KG
2. SNAPPE II Score < 7 |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Anastomotic stricture |
2 weeks, 1 month, 3 months, 6 months |
| Time to start feed |
post operative period |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |