CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Fecobionicsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03885999
NCT03885999N/ACompleted

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

Giome·interventional·Posted Mar 22, 2019·Updated Jan 19, 2022

In Brief

A clinical study evaluating Fecobionics for Anterior Resection Syndrome and Bowel Dysfunction. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartMay 29, 2019
Primary CompletionFeb 1, 2020
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.3 years ago

Interventions

Fecobionicsdevice

Fecobionics is a new device for studying defecation