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临床试验/NCT04067453
NCT04067453已完成不适用

External Anal Sphincter Fatigability, an Electromyographic and Manometric Study

Gérard Amarenco1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Variation in electromyographic muscle response 1

研究概览

简要总结

External anal sphincter is a Skeletal muscle under voluntary control. As described in previous studies, it is mainly composed of type 1 fibers. Fatigability is a concept which has been studied and described many times in skeletal limbs muscles. Two types of fatigue are described, peripheral of central fatigue. Fatigue can been physiologic but also pathologic (due to an affection of the muscle, the peripheral nervous system or the central nervous system). Many tools have been used to measure muscle fatigability (direct strength measure on isometric contraction, electromyography, echography, oxymetry...).

Besides many fatiguing methods have been developed for every each muscle depending on its histological structure.

Anal sphincter fatigability has already been described in few manometric studies with particularly 2 measures: Fatigue Rate and Fatigue Rate Index. Moreover, no fatiguing protocol has been standardized to study it.

The primary aim of this study is to define a fatiguing protocol for external anal sphincter in order to study it in further studies. Secondary aims are to assess Electromyography as a tool for measuring this fatigability and finally to assess the link between anal sphincter fatigability and symptoms reported by patients.

Patients over 18 years old, consulting for an Anorectal Manometry with a voluntary command on the external anal sphincter are included.

History and treatment, height, weight, sex, age, Fatigue impact scale, digestive symptoms with Neurologic Bowel Disorders score and Wexner scale, urinary tract symptoms with Urinary Symptom Profile (USP) score and electromyography (Root Mean Square (RMS) and Mean Power Frequency (MPF)) and manometric data (contraction peak, fatigue rate, fatigue rate index) were recorded.

The fatiguing protocol consists in 10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting. A training contraction is made before the fatiguing protocol. At the end of the protocol, patients undergo a classical anorectal manometry.

Primary outcome is the difference on root mean square in electromyography between the first and the last fatiguing contraction.

Secondary outcomes were mean power frequency and manometric data (i.e. Fatigue Rate index (FRI), Fatigue Rate (FR), contraction Peak)

Influence of age, sex, symptoms, pathologies, weight on fatigability will be studied in a second analysis

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years old
  • voluntary command on external anal sphincter contraction during physical examination
  • Anorectal disorders

排除标准

  • inability to understand simple orders

结局指标

主要结局

Variation in electromyographic muscle response 1

时间窗: 1 day

Difference between first and last fatiguing contractions on surface electromyographic Root Mean Square (RMS)

次要结局

  • variation of electromyographic muscle response 2(1 day)
  • variation of external anal sphincter contractions with manometry 1(1 day)
  • variation of external anal sphincter contractions with manometry 2(1 day)
  • variation of external anal sphincter contractions with manometry 3(1 day)

研究者

发起方
Gérard Amarenco
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gérard Amarenco

Head of Neuro-Urology department, Tenon Hospital

Pierre and Marie Curie University

研究点 (1)

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