Studies in Patients With Low Anterior Resection Syndrome (LARS)

NCT03885999 | Completed Results

• 1 other identifier: 2018.640
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Resection Syndrome; Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fecobionics studies

EXPERIMENTAL

Device: Fecobionics

Interventions

Fecobionics DEVICE

Fecobionics is a new device for studying defecation

Fecobionics studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older with history of LARS over 3 months.
• Informed, written consent by the patient

You may not qualify if:

• Patients who are not willing to undergo the specified tests in this study
• Pregnant women

Sponsors & Collaborators

• Giome: lead

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Kaori Futaba
• Organization: The Chinese University of Hong Kong, Department of Surgery, Prince of Wales Hospital

kfutaba@surgery.cuhk.edu.hk

0085264630121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 22, 2019
• Study Start: May 29, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2021-12

Locations

HK (1)