跳至主要内容
临床试验/CTRI/2025/01/079507
CTRI/2025/01/079507尚未招募不适用

Prevalence of Dyssynergic Defecation among children aged 5 to 12 years with Functional constipation and the role of biofeedback therapy among children with Dyssynergic Defecation

Department of Paediatric Gastroenterology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To determine whether biofeedback therapy in addition to standard laxative treatment is superior for treatment of Dyssynergic Defecation among children aged 5 to 12 years.

研究概览

简要总结

Functional constipation is a leading cause of pediatric gastroenterologist consultations, comprising approximately 25% of cases, with a prevalence rate of up to 32.2%. As of now, there is no consensus as to how long to continue treatment for functional constipation in children and there is paucity of data on High resolution anorectal manometry findings in children with functional constipation. Studies have reported the prevalence of Dyssynergic defecation in children till 80%. Dyssynergic defecation (DD) is one of the cause of failure of standard treatment and longer treatment. Biofeedback id the mainstay of treatment for adults with Dyssynergic defecation At present, due to under recognition and underreporting of this entity, diagnostic criteria for DD are based on studies in adults and the utility of biofeedback is hardly studied in children. Hence this study is aimed at determining the role of biofeedback with laxatives compared to laxatives.

 Hypothesis: As Dyssynergic Defecation is increasingly prevalent in the children with constipation between 5-12 years, and high rate of incomplete cure and relapse is identified, it is hypothesized that treatment with biofeedback therapy  in addition to laxatives will achieve a higher rate of response compared to the group of laxatives alone.

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
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children between 5year to 12 years of age diagnosed with functional constipation fulfilling ROME IV criteria and diagnosed with Dyssynergic defecation by anorectal manometry in Institute of Child health and Hospital for Children.

排除标准

  • Non Retentive Encopresis
  • Organic Cause of constipation
  • Developmental delay, Cognitive disabilities.

结局指标

主要结局

To determine whether biofeedback therapy in addition to standard laxative treatment is superior for treatment of Dyssynergic Defecation among children aged 5 to 12 years.

时间窗: Symptom improvement monitoring at 1 week, 2 week, 1 month, 2 months and 3 months and Anorectal manometry at the time of recruitment and at the end of 3 months

次要结局

  • To determine the response and the changes in anorectal manometry after standard laxative treatment and biofeedback plus laxative(AT the end of 3 months after starting treatment)

研究者

发起方
Department of Paediatric Gastroenterology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Deepa J

Institute of child health and hospital for children,

研究点 (1)

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