Anal Canal Functional Assessment Using EndoFLIP

NCT04741893 | Completed DMC

• 1 other identifier: CREC2017.125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence; Asymptomatic Condition

Keywords

Faecal incontinence; Functional Lumen Imaging Probe; Anal distensibility

Outcome Measures

Primary Outcomes (2)

• 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

• Abnormal anal distensibility in faecally incontinent group

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

  1 day

Study Arms (2)

faecally incontinent patients

EXPERIMENTAL

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

Device: EndoFLIP

Asymptomatic individuals

EXPERIMENTAL

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

Device: EndoFLIP

Interventions

EndoFLIP DEVICE

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

Asymptomatic individuals; faecally incontinent patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• For Faecally Incontinent Group:

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Related Publications (3)

• 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.

  PMID: 5212375 BACKGROUND

• 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.

  PMID: 24286561 BACKGROUND

• 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.

  PMID: 26670599 BACKGROUND

MeSH Terms

Conditions

Encopresis; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Kaori Futaba

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 5, 2021
• Study Start: August 14, 2017
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

HK (1)