Studies in Patients With Low Anterior Resection Syndrome (LARS)

December 21, 2021 updated by: Hans Gregersen, Giome

Functional Anorectal 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 0000
        • Department of Surgery, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecobionics studies
Device: Fecobionics
Fecobionics is a new device for studying defecation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and following intervention, approximately 30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.640

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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