Studies in Patients With Low Anterior Resection Syndrome (LARS)

• Sponsor: Giome (Other)
• Overall Status: Completed
• CT.gov ID: NCT03885999
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Resection Syndrome; Bowel Dysfunction	Device: Fecobionics	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Functional Anorectal Studies in Patients With Low Anterior Resection Syndrome (LARS)
• Actual Study Start Date: May 29, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of Anorectal Pressure Assessed With the Fecobionics Device [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Prince of Wales Hospital	Hong Kong		Hong Kong	0000

Sponsors and Collaborators

• Giome

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2020

More Information

Publications

None provided.

• Responsible Party: Hans Gregersen, Professor, Giome
• ClinicalTrials.gov Identifier: NCT03885999
• Other Study ID Numbers: 2018.640
• First Posted: Mar 22, 2019
• Last Update Posted: Jan 19, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases; Syndrome

Study Results

Participant Flow

Recruitment Details	This study was conducted at at Prince of Wales Hospital in Hong Kong from 29 May 2019 to 9 December 2019. The protocol was approved by the Ethics Review Committees of the involved hospital (CRE-2018.640). Written informed consent was obtained from each subject prior to commencement of the study.

Arm/Group Title	Fecobionics Studies
Arm/Group Description	Fecobionics: Fecobionics is a new device for studying defecation
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Fecobionics Studies
Arm/Group Description	Fecobionics: Fecobionics is a new device for studying defecation
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 54.5%
>=65 years	5 45.5%
Sex: Female, Male (Count of Participants)
Female	5 45.5%
Male	6 54.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	11 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Hong Kong	11 100%
LARS score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	39

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

11 LARS patients

Arm/Group Title	Fecobionics Studies
Arm/Group Description	Fecobionics: Fecobionics is a new device for studying defecation
Measure Participants	11
Mean (Standard Error) [cmH2O]	9.8 (2.1)

Adverse Events

Time Frame	9 months
Adverse Event Reporting Description	Same definitions as the clinicaltrials.gov.
Arm/Group Title	Fecobionics Studies
Arm/Group Description	Fecobionics: Fecobionics is a new device for studying defecation
All Cause Mortality
	Fecobionics Studies
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Fecobionics Studies
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Gastrointestinal disorders
Perforation	1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	Fecobionics Studies
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.