| CTRI Number |
CTRI/2021/03/031844 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
3D- Models for anorectal malformation |
|
Scientific Title of Study
|
Patient specific three-dimensional printed models of aberrant anatomy for surgical planning of anorectal malformation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJAN KUMAR DHUA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 4002 Dept of Paediatric Surgery,
Teaching Block,
AIIMS, Ansari Nagar Delhi
South
DELHI
110029
India |
| Phone |
26593309 |
| Fax |
|
| Email |
anjandhua@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANJAN KUMAR DHUA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 4002 Dept of Paediatric Surgery,
Teaching Block,
AIIMS, Ansari Nagar Delhi
DELHI
110029
India |
| Phone |
26593309 |
| Fax |
|
| Email |
anjandhua@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANJAN KUMAR DHUA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS, Delhi |
| Address |
Room No 4002 Dept of Paediatric Surgery,
Teaching Block,
AIIMS, Ansari Nagar Delhi
DELHI
110029
India |
| Phone |
26593309 |
| Fax |
|
| Email |
anjandhua@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
AIIMS, Ansari Nagar, Delhi 110029 |
| 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 |
| Anjan Kumar Dhua |
AIIMS Delhi |
Department of Paediatric Surgery
AIIMS, Ansari nagar
South
DELHI |
9871568690
anjandhua@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q420||Congenital absence, atresia and stenosis of rectum with fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional pressure augmented colostogram |
Being a case-crossover, same cases before the intervention (3d Model), a questionnaire to surgeon will be provided to prospective surgeon after showing the conventional colostogram as to their choice of surgery for definitive reconstruction of the anomaly, and recorded. |
| Intervention |
CT colostogram and 3D model fabrication |
Dyna-CT images will be imported into a 3DSlicer (Brigham and Women’s Hospital, Boston MA, USA) and the bladder, rectum, recto-urethral distal fistula, if visible, pelvic bones, sacrum with coccyx and the levator ani muscle will be segmented using thresholding-based segmentation with manual editing performed by an expert pediatric radiologist, with more than 10 years expertise in pediatric imaging. Segmented data will be exported from the 3DSlicer as standard tessellation language (STL) files and additional model editing will be performed using Software of choice to ensure that the model is manifold (properly triangulated for printing). Appropriate supports will be used to represent the perineal opaque marker. The model will be printed using a fully biodegradable thermoplastic polylactic acid (PLA) filament based fused deposition modeling-style printer. The skeletal model will be printed using white PLA and the soft tissues will colored appropriately to enhance the comprehensibility of the model. Post processing will be performed as required. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Male |
| Details |
Male patient with anorectal anomaly with colostomy done in neonatal period and waiting for a definitive repair in whom the pressure augmented colostogram does not reveal an obvious urethral communication with the terminal portion of bowel. |
|
| ExclusionCriteria |
| Details |
1. Patients in whom a prior lower abdominal/pelvic surgery/urological has been done before.
2. Patients in whom a prior surgery in the perineum or exploration has been done before.
3. Patients having a concomitant cardiac anomaly severe enough to preclude administering
sedation or anesthesia as decided by a consultant anesthetist.
4. Patients in whom urethral catheterization fails by a trained surgical resident with a minimum
of 3 years’ experience after medical graduation (senior resident).
5. ARM associated with caudal regression syndrome (a disorder that impairs the development
of the lower (caudal) half of the body. Affected areas can include the lower back, sacrum, pelvis, limbs, the genitourinary tract, and the gastrointestinal tract. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of models-Agreement between caliper measurements on the 3D model and measurements on CT (Mean difference ±SD in mm) |
4 weeks from Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact on the decision making on the surgical management of ARM |
8 weeks from intervention |
| Surgeon Satisfaction survey questionnaire |
10 weeks from Intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We would objectively investigate the impact of 3D models on the surgical decision change of 30 male patients with ARM. We would be able to show that 3D models are accurate replicas of the aberrant anorectal pelvic anatomy. Whether, 3D models support the surgical decision (in comparison to pressure augmented colostogram) with no changes in the surgical approach would be substantiated. Favorable findings, if found would provide evidence to expand the utility of 3D printed models in other complex anorectal malformation (cloacal anomalies, etc.) and also to other congenital anomalies that a Paediatric surgeon often comes across. Aim: To validate and generate evidence on the utility of 3D printed models for planning definitive surgery for anorectal anomalies.
Primary objective
To assess whether patient specific 3D printed models of the pelvis in male patients with ARM waiting for definitive repair after having undergone a colostomy in the neonatal period are accurate.Secondary objective To assess whether patient specific 3D printed models have an impact on the decision making on the surgical management of ARM To assess whether patient specific 3D printed models improve the overall satisfaction of the Paediatric surgeon in managing ARMs.
|