Studies in Patients With Low Anterior Resection Syndrome (LARS)

Bowel Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885999
• Other study ID #: 2018.640
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2021
• Source: Giome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Resection Syndrome
• Bowel Dysfunction
• Intestinal Diseases
• Syndrome

Intervention

Device:
• Fecobionics
Fecobionics is a new device for studying defecation

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Giome

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and following intervention, approximately 30 seconds