Studies in Patients With Low Anterior Resection Syndrome (LARS)

Study Overview
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Brief Summary
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Colorectal Cancer is the commonest cancer diagnosed for both genders combined in Hong Kong. In 2015 16.6% of all new cancer cases registered on the Hong Kong registry were cancer of colon and rectum. With recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal or coloanal anastomosis to avoid permanent stoma. Up to 80% of patients who has undergone low anterior resection (LAR), suffer from severe bowel dysfunction post operatively. Patients may suffer from a wide range of symptoms from incontinence, frequency, and urgency to constipation and feelings of incomplete emptying. This combination of symptoms after LAR is referred to as Low Anterior Resection Syndrome (LARS) which is associated with negative impact on quality of life (QoL). Originally, it was thought that these symptoms were due to early postoperative changes. Many studies report that the majority of patients experience longterm changes in quality of life after LAR. Therefore, a large number of patients worldwide are suffering from unpredictable, poor bowel function postoperatively affecting their day-to-day activity and quality of life. The cause of LARS is often multifactorial and difficult to define. Unfortunately, there is no cure for LARS at present. This trial is designed to use Fecobionics, a new Hong Kong based innovation of a simulated stool, to provide new mechanistic insights regarding anorectal physiological function post low anterior resection to understand the condition better to improve their treatment options.

Official Title
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Functional Anorectal Studies in Patients With Low Anterior Resection Syndrome (LARS)

Conditions
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Bowel Dysfunction, Anterior Resection Syndrome

Intervention / Treatment
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* Device: Fecobionics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older with history of LARS over 3 months. Informed, written consent by the patient Exclusion Criteria: Patients who are not willing to undergo the specified tests in this study Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecobionics studies<br> | Device: Fecobionics<br>* Fecobionics is a new device for studying defecation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Anorectal Pressure Assessed With the Fecobionics Device | The expected outcome is that the device will perform as shown in the previous human experiments (n>60) where no adverse effects have been recorded. | baseline and following intervention, approximately 30 seconds |