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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03885999
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : June 4, 2019
Information provided by (Responsible Party):
Hans Gregersen, Giome

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.

Condition or disease Intervention/treatment Phase
Anterior Resection Syndrome Bowel Dysfunction Device: Fecobionics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Anorectal Studies in Patients With Low Anterior Resection Syndrome (LARS)
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Fecobionics studies Device: Fecobionics
Fecobionics is a new device for studying defecation

Primary Outcome Measures :
  1. Change of anorectal pressure assessed with the Fecobionics device [ Time Frame: 1 year ]
    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.

  2. Rate of patients develop LARS with the Fecobionics device [ Time Frame: 1 year ]
    The expected outcome is that the studies will provide accurate data and biomarkers.

  3. Change of anorectal angle assessed with the Fecobionics device [ Time Frame: 1 year ]
    The expected outcome is that to derive outcome measures reflecting the beneficial effect of treatment.

Secondary Outcome Measures :
  1. Change of anorectal mechanical stress assessed with the Fecobionics device [ Time Frame: 1 year ]
    The number of LARS patients with low anorectal mechanical stress during defecation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03885999

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Contact: Hans Gregersen, PhD 0085290841020

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Hong Kong
Department of Surgery, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, 0000
Contact: Hans Gregersen, PhD    0085290841020   
Sponsors and Collaborators
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Responsible Party: Hans Gregersen, Professor, Giome Identifier: NCT03885999    
Other Study ID Numbers: 2018.640
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases