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Anal Canal Functional Assessment Using EndoFLIP

NCT04741893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Faecal Incontinence
  • Asymptomatic Condition

Interventions

DEVICE

EndoFLIP

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Kaori Futaba · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2019-03-27
Completion
2019-03-27

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741893 on ClinicalTrials.gov