| CTRI Number |
CTRI/2024/05/067931 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Primary versus Rotational Flap Closure in Open Neural tube Defects |
|
Scientific Title of Study
|
​​A Randomised Control Study comparing Primary versus Rotational Flap Closure in Pediatric Open Neural Tube Defect Closure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhalaxmi Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Pediatric Surgery, AIIMS Jodhpur |
| Address |
Department of Pediatric Surgery AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9742022426 |
| Fax |
|
| Email |
drshubhanyk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhalaxmi Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Pediatric Surgery, AIIMS Jodhpur |
| Address |
Room 228, Department of Pediatric Surgery, All India Institute of Medical Sciences Jodhpur,342005, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9742022426 |
| Fax |
|
| Email |
drshubhanyk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhalaxmi Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Department of Pediatric Surgery, AIIMS Jodhpur |
| Address |
Room 228, Department of Pediatric Surgery, All India Institute of Medical Sciences Jodhpur,342005, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9742022426 |
| Fax |
|
| Email |
drshubhanyk@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Shubhalaxmi Nayak |
| Address |
Room 228, Department of Pediatric Surgery, All India Institute of Medical Sciences Jodhpur,342005, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Shubhalaxmi Nayak |
All India Institute of Medical Sciences Jodhpur |
Room 228, Department of Pediatric Surgery, All India Institute of Medical Sciences Jodhpur, 342005,Rajasthan, India
Jodhpur
RAJASTHAN |
9742022426
drshubhanyk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q059||Spina bifida, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Primary closure |
The measurement of skin defect size will be done on OT table after dural closure. Those with defect size more than 5cm will be randomised into two groups for either a primary or a rotational flap closure. |
| Intervention |
Rotational Flap Closure |
The measurement of skin defect size will be done on OT table after dural closure. Those with defect size more than 5cm will be randomised into two groups for either a primary or a rotational flap closure. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Infants under 3 months of age
Diagnosis of open neural tube defect of defect size greater than 5cm longest diameter of skin defect which is measured after dural closure on the OT table
Consent from parents or legal guardians obtained
|
|
| ExclusionCriteria |
| Details |
Patients with ONTDs of over 3 months of age
Patients with closed neural tube defects
Lack of parental or legal guardian consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stay |
Assessment at baseline after surgery and at follow up after 1 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rates of dehiscence, infection, cerebrospinal fluid leakage, operative duration, the need for a second surgery, length of hospital stay |
by 1 year of follow up |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
05/06/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is anticipated in this randomised control trial, that rotational flap closure will demonstrate comparable or superior outcomes in terms of reduced rates of dehiscence, wound infection, cerebrospinal fluid leakage, and the need for a second surgery when compared to primary closure and this may reduce the morbidity altogether in a one-time procedure with comparable operative duration. Additionally, if rotational flap closure proves to be a viable alternative, a shorter hospital stay is expected for infants undergoing this procedure. The study aims to provide valuable insights into refining the surgical management of open neural tube defects in infants, potentially influencing future clinical practices and improving the overall quality of care for these patients. |