Studies in Patients With Low Anterior Resection Syndrome (LARS)

NCT ID: NCT03885999

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2020-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fecobionics studies

Group Type: EXPERIMENTAL

Fecobionics

Intervention Type: DEVICE

Fecobionics is a new device for studying defecation

Interventions

Fecobionics

Fecobionics is a new device for studying defecation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giome

OTHER

Sponsor Role: lead

Responsible Party

Hans Gregersen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Surgery, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018.640

Identifier Type: -

Identifier Source: org_study_id