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Studies in Patients With Low Anterior Resection Syndrome (LARS)

G

Giome

Status

Completed

Conditions

Anterior Resection Syndrome
Bowel Dysfunction

Treatments

Device: Fecobionics

Study type

Interventional

Funder types

Other

Identifiers

NCT03885999
2018.640

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Fecobionics studies
Experimental group
Treatment:
Device: Fecobionics

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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