Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
NCT Number: NCT04741893
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.
Looking for future studies?
Notify Me30 year and older
All sexes
Interventional
Not applicable
Shatin, New Territories, Hong Kong
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.
Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function
Time frame: 1 day
Comparison of anal distensibility in between different age groups in asymptomatic individuals
Time frame: 1 day
Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP
Chinese University of Hong Kong
Other
Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP
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.
Published trials that share one or more normalized conditions with this study.
NCT05864807
Behavior, Behavioral Symptoms
Barcelona, Spain
View Trial DetailsNCT04657588
Behavior, Behavioral Symptoms
Maastricht, Limburg, Netherlands
View Trial DetailsNCT06593743
Behavior, Behavioral Symptoms
Nottingham, United Kingdom
View Trial DetailsNCT06593730
Behavior, Behavioral Symptoms
View Trial Details