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Completed

NCT Number: NCT04741893

Anal Canal Functional Assessment Using EndoFLIP

Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. FI can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that FI is difficult to identify the exact cause of patients' incontinence.

Current assessment of patients with FI include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. Anorectal manometry is a simple test to perform but Anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with FI. Harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze.

Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology used to measure the dimensions and function of a hollow organ. Limited publication so far has shown that EndoFLIP© provides a new way of assessing anal sphincter competence. The study is to assess the use of EndoFLIP© to assess anal sphincter function in Hong Kong population. Firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For Asymptomatic Group:

Inclusion criteria

adults over 30 with no history of faecal incontinence, who are able to give consent.

Exclusion criteria

Patients with history of gastrointestinal disease on medication or neurological disorder with bowel symptoms, anorectal surgery or previous bowel resection. Patients who are not willing to undergo the specified tests in this study. Pregnant women.

For Faecally Incontinent Group:

Inclusion criteria

Adults over 30 with history of faecal incontinence for over 3months, who are able to give consent.

Exclusion criteria

Patients who are not willing to undergo the specified tests in this study. Pregnant women and patients who has had anorectal surgery or bowel resection.

Treatment and study plan

EndoFLIP

Device

Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function

Primary outcomes

  1. Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP

    Time frame: 1 day

    Comparison of anal distensibility in between different age groups in asymptomatic individuals

  2. Abnormal anal distensibility in faecally incontinent group

    Time frame: 1 day

    Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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