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Studies in Patients With Low Anterior Resection Syndrome (LARS)

Primary Purpose

Anterior Resection Syndrome, Bowel Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Fecobionics

About this trial

This is an interventional diagnostic trial for Anterior Resection Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Surgery, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecobionics studies

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03885999

First Posted

March 12, 2019

Last Updated

December 21, 2021

Sponsor

Giome

1. Study Identification

Unique Protocol Identification Number

NCT03885999

Brief Title

Studies in Patients With Low Anterior Resection Syndrome (LARS)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 29, 2019 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Giome

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Resection Syndrome, Bowel Dysfunction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fecobionics studies

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Fecobionics

Intervention Description

Fecobionics is a new device for studying defecation

Primary Outcome Measure Information:

Title

Change of Anorectal Pressure Assessed With the Fecobionics Device

Description

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.

Time Frame

baseline and following intervention, approximately 30 seconds

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Surgery, Prince of Wales Hospital

City

Hong Kong

ZIP/Postal Code

0000

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Studies in Patients With Low Anterior Resection Syndrome (LARS)

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