3D- Models for anorectal malformatio
- Conditions
- Health Condition 1: Q420- Congenital absence, atresia and stenosis of rectum with fistula
- Registration Number
- CTRI/2021/03/031844
- Lead Sponsor
- AIIMS Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Impact on the decision making on the surgical management of ARMTimepoint: 8 weeks from intervention;Surgeon Satisfaction survey questionnaireTimepoint: 10 weeks from Intervention