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Anal Canal Functional Assessment Using EndoFLIP

Primary Purpose

Faecal Incontinence, Asymptomatic Condition

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EndoFLIP
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Faecal Incontinence focused on measuring Faecal incontinence, Functional Lumen Imaging Probe, Anal distensibility

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Surgery, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

faecally incontinent patients

Asymptomatic individuals

Arm Description

faecally incontinent patients are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound

asymptomatic individuals are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound

Outcomes

Primary Outcome Measures

Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP
Comparison of anal distensibility in between different age groups in asymptomatic individuals
Abnormal anal distensibility in faecally incontinent group
Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP

Secondary Outcome Measures

Full Information

First Posted
February 19, 2018
Last Updated
February 3, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04741893
Brief Title
Anal Canal Functional Assessment Using EndoFLIP
Official Title
Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence, Asymptomatic Condition
Keywords
Faecal incontinence, Functional Lumen Imaging Probe, Anal distensibility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
faecally incontinent patients
Arm Type
Experimental
Arm Description
faecally incontinent patients are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound
Arm Title
Asymptomatic individuals
Arm Type
Experimental
Arm Description
asymptomatic individuals are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound
Intervention Type
Device
Intervention Name(s)
EndoFLIP
Intervention Description
Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function
Primary Outcome Measure Information:
Title
Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP
Description
Comparison of anal distensibility in between different age groups in asymptomatic individuals
Time Frame
1 day
Title
Abnormal anal distensibility in faecally incontinent group
Description
Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaori Futaba
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Chinese University of Hong Kong
City
Shatin
State/Province
New Territories
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
5212375
Citation
Harris LD, Winans CS, Pope CE 2nd. Determination of yield pressures: a method for measuring anal sphincter competence. Gastroenterology. 1966 Jun;50(6):754-60.
Results Reference
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PubMed Identifier
24286561
Citation
Sorensen G, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K. Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Neurogastroenterol Motil. 2014 Feb;26(2):255-63. doi: 10.1111/nmo.12258. Epub 2013 Nov 29.
Results Reference
background
PubMed Identifier
26670599
Citation
Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotte P, Leroi AM. Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Neurogastroenterol Motil. 2016 Mar;28(3):399-409. doi: 10.1111/nmo.12740. Epub 2015 Dec 15.
Results Reference
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Anal Canal Functional Assessment Using EndoFLIP

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