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3D- Models for anorectal malformation

Patient specific three-dimensional printed models of aberrant anatomy for surgical planning of anorectal malformation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031844
Enrollment
30
Registered
2021-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q420- Congenital absence, atresia and stenosis of rectum with fistula

Interventions

Intervention1: CT colostogram and 3D model fabrication: Dyna-CT images will be imported into a 3DSlicer (Brigham and Womenâ??s Hospital, Boston MA, USA) and the bladder, rectum, recto-urethral distal

Sponsors

AIIMS Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 yearsâ?? 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.

Design outcomes

Primary

MeasureTime frame
Accuracy of models-Agreement between caliper measurements on the 3D model and measurements on CT (Mean difference ±SD in mm)Timepoint: 4 weeks from Intervention

Secondary

MeasureTime frame
Impact on the decision making on the surgical management of ARMTimepoint: 8 weeks from intervention;Surgeon Satisfaction survey questionnaireTimepoint: 10 weeks from Intervention

Countries

India

Contacts

Public ContactANJAN KUMAR DHUA

AIIMS, Delhi

anjandhua@hotmail.com26593309

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026