Patient specific three-dimensional printed models of aberrant anatomy for surgical planning of anorectal malformation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy of models-Agreement between caliper measurements on the 3D model and measurements on CT (Mean difference ±SD in mm)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •Patients in whom a prior lower abdominal/pelvic surgery/urological has been done before.
- •Patients in whom a prior surgery in the perineum or exploration has been done before.
- •Patients having a concomitant cardiac anomaly severe enough to preclude administering sedation or anesthesia as decided by a consultant anesthetist.
- •Patients in whom urethral catheterization fails by a trained surgical resident with a minimum of 3 years’ experience after medical graduation (senior resident).
- •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.
结局指标
主要结局
Accuracy of models-Agreement between caliper measurements on the 3D model and measurements on CT (Mean difference ±SD in mm)
时间窗: 4 weeks from Intervention
次要结局
- Impact on the decision making on the surgical management of ARM(8 weeks from intervention)
- Surgeon Satisfaction survey questionnaire(10 weeks from Intervention)