NCT03885999

Studies in Patients With Low Anterior Resection Syndrome (LARS)

Completed NA Results posted Last updated 19 January 2022

What this trial tests

NA trial testing Fecobionics in Anterior Resection Syndrome in 12 participants. Completed in 1 March 2020.

Timeline

29 May 2019

Primary endpoint
1 February 2020

1 March 2020

Quick facts

Lead sponsor	Giome
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	12
Start date	29 May 2019
Primary completion	1 February 2020
Estimated completion	1 March 2020
Sites	1 location across Hong Kong

Drugs / interventions tested

• Fecobionics

Conditions studied

• Anterior Resection Syndrome — all drugs for Anterior Resection Syndrome →
• Bowel Dysfunction — all drugs for Bowel Dysfunction →

Sponsor

Giome

Who can join

18 and older, any sex, with Anterior Resection Syndrome or Bowel Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change of Anorectal Pressure Assessed With the Fecobionics Device Primary · 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.

Group	Value	95% CI
Fecobionics Studies	9.8	± 2.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fecobionics Studies

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (1 terms)

Reaction	System	Fecobionics Studies
Perforation	Gastrointestinal disorders	—

Most-reported serious reactions: Perforation.

Data from ClinicalTrials.gov NCT03885999 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.