Anal Canal Functional Assessment Using EndoFLIP

Faecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741893
• Other study ID #: CREC2017.125
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: March 27, 2019

Study information

• Verified date: February 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases
• Faecal Incontinence
• Fecal Incontinence

Intervention

Device:
• EndoFLIP
Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotté 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. — View 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. — View Citation

Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP	Comparison of anal distensibility in between different age groups in asymptomatic individuals	1 day
Primary	Abnormal anal distensibility in faecally incontinent group	Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP	1 day