The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the manometric parameters in children with chronic refractory constipation
研究概览
简要总结
Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia
详细描述
Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.
Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged from 4 to 16 years.
- •Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.
- •At least 2 of the following present at least once per week for at least 1 month:
- •2 or fewer defecations in the toilet per week
- •At least 1 episode of fecal incontinence per week
- •History of retentive posturing or excessive volitional stool retention
- •History of painful or hard bowel movements
- •Presence of a large fecal mass in the rectum
- •History of large-diameter stools that may obstruct the toilet The symptoms cannot be fully explained by another medical condition (Hyams et al., 2016).
- •Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.
- •5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
排除标准
- •participants who have anorectal malformation
- •participants who have neurological disease affecting lower limbs
- •Has a history of hypersensitivity or allergies to lubiprostone
研究组 & 干预措施
single arm as all participant will receive the treatment
all participant will receive lubiprostone
干预措施: lubiprostone , single arm (Drug)
single arm as all participant will receive the treatment
all participant will receive lubiprostone
干预措施: biofeed back sessions (Procedure)
single arm as all participant will receive the treatment
all participant will receive lubiprostone
干预措施: botox injection (Procedure)
结局指标
主要结局
To evaluate the manometric parameters in children with chronic refractory constipation
时间窗: 1 year
To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction.
evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation
时间窗: 1 month
Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
次要结局
- To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity(3 months)
- To determine the effect of cow milk protein free diet on chronic refractory constipation in children(1 month)
- To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure(3 month)
研究者
asmaa abdelnaby
assistant lecturer of pediatrics
Ain Shams University