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OpenTrials
Completed

NCT Number: NCT03885999

Studies in Patients With Low Anterior Resection Syndrome (LARS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Prince of Wales Hospital

Hong Kong, 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecobionics

Device

Fecobionics is a new device for studying defecation

Primary outcomes

  1. Change of Anorectal Pressure Assessed With the Fecobionics Device

    Time frame: baseline and following intervention, approximately 30 seconds

    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.

Sponsors and collaborators

Lead sponsor

Giome

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Jan 19, 2022

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.