| CTRI Number |
CTRI/2025/08/093003 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking how children grow and develop after surgery for a food pipe problem(esophageal atresia with tracheo-esophageal fistula) — comparing keyhole surgery(thoracoscopy) with open-chest surgery.(thoracotomy) |
|
Scientific Title of Study
|
Multi-dimensional developmental assessment of patients who underwent thoracoscopic repair of Esophageal atresia: A prospective comparison with thoracotomy cohort |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rudri Joshipura |
| Designation |
Senior resident |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Post graduate institute of medical education and research, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9409258742 |
| Fax |
|
| Email |
rudrijoshipura@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Ravi Kanojia |
| Designation |
Professor, pediatric surgery department |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Post graduate institute of medical education and research, sector 12, Chandigarh, India
pin code- 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7888972499 |
| Fax |
|
| Email |
drravikanojia@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rudri Joshipura |
| Designation |
Senior resident |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Post graduate institute of medical education and research, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9409258742 |
| Fax |
|
| Email |
rudrijoshipura@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical research and education, Chandigarh, India,160012 |
|
|
Primary Sponsor
|
| Name |
Peditric surgery department PGIMER Chandigarh |
| Address |
Post graduate institute of medical education and research, Chandigarh, India, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rudri Joshipura |
Post graduate institute of medical education and research, Chandigarh |
Post graduate institute of medical education and research, sector 12,Chandigarh
Chandigarh
CHANDIGARH |
09409258742
rudrijoshipura@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q391||Atresia of esophagus with tracheo-esophageal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age: 2 years and above
Gender: male and female
informed consent taken
All the patients who had tracheo-esophageal fistula with thoracoscopic repair of esophageal atresia
All the patients who had thoracotomy for esophageal atresia repair
minimum 2 years of follow up after surgery
gestational age greater than 35 weeks
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Neurodevelopmental outcome assessment of neonates who underwent
thoracoscopic repair of Esophageal atresia and repair via open thoracotomy at
birth using defined assessment methods with comparison between the two
groups.
2. Formulate a standard assessment methodology for neurodevelopmental
assessment of surgical patients undergoing complex and major surgical
procedures at birth |
After 2 years of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Make comparative assessment of musculoskeletal development and problems in
patients operated via thoracotomy and thoracoscopy
2. Make comparative assessment of general physical development by means of
anthropometry in patients operated via thoracotomy and thoracoscopy |
2 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/08/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Summary
Setting Department of Pediatric Surgery PGIMER Chandigarh Subjects Patients with TREAT repaired via thoracotomy or thoracoscopy
Inclusion Criteria
Patients with TREAT and expectant recovery postnatally
Thoracotomy or thoracoscopic repair performed for esophageal atresia
Minimum 2 years of completed follow-up
Conversions to open surgery included in open group
Patients undergoing esophageal dilatation under general anesthesia included
Gestational age more than 35 weeks
Exclusion Criteria
Less than 2 years of follow-up
Major surgeries for other systems such as cardiac surgery
Anastomotic leak requiring more than 3 weeks of ventilation or esophageal diversion
Syndromic patients with cognitive or neurological impairment
Lost to follow-up cases
Perinatal asphyxia defined by WHO or APGAR less than 7
Preterm neonates less than 35 weeks gestation |