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.|
|ClinicalTrials.gov Identifier: NCT03885999|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : June 4, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Fecobionics studies||
Fecobionics is a new device for studying defecation
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885999
|Contact: Hans Gregersen, PhDemail@example.com|
|Department of Surgery, Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong, 0000|
|Contact: Hans Gregersen, PhD 0085290841020 firstname.lastname@example.org|