临床试验/CTRI/2024/09/074338

CTRI/2024/09/074338尚未招募不适用

Comparison of continence in female patients with Anorectal Malformations (ARM) undergoing placement of neoanus based on Caudal Termination of the Striated Muscle Complex (SMC) vs anal dimple - An open- label randomized control trial.

Amit kumar1 个研究点分布在 1 个国家目标入组 96 人开始时间: 2024年10月9日最近更新: 2024年9月19日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 96
试验地点: 1
主要终点: To compare the postoperative fecal continence in patients with anorectal malformations undergoing placement of neoanus based on the anal dimple versus the caudal termination of the striated muscle complex during PSARP.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

the study aims at a novel technique of attaining good fecal continence in operated cases of anorectal malformations. It will utilise specialised surgical techniques to see how it affects the clinical outcomes in terms of fecal continence.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 3.00 Month(s) 至 6.00 Year(s)（—）
性别: Female

入选标准

•ALL FEMALES IN THIS AGE GROUP WITH ANOVESTIBULAR FISTULA UNDERGOING PSARP.

排除标准

•Redo PSARP Severe perineal malformations Poorly developed Anal dimple.

结局指标

主要结局

To compare the postoperative fecal continence in patients with anorectal malformations undergoing placement of neoanus based on the anal dimple versus the caudal termination of the striated muscle complex during PSARP.

时间窗: 3month,6month,9months and 12 months 1 year post surgery.

次要结局

1. To assess the relationship between striated muscle complex and anal dimple.

研究者

发起方

Amit kumar

申办方类型

Research institution

责任方

Principal Investigator

主要研究者

DR AMIT KUMAR

AIIMS PATNA

研究点 (1)

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