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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecobionics studies | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecobionics | Device | Fecobionics is a new device for studying defecation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Prince of Wales Hospital | Hong Kong | 0000 | Hong Kong |
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This study was conducted at at Prince of Wales Hospital in Hong Kong from 29 May 2019 to 9 December 2019. The protocol was approved by the Ethics Review Committees of the involved hospital (CRE-2018.640). Written informed consent was obtained from each subject prior to commencement of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecobionics Studies | Fecobionics: Fecobionics is a new device for studying defecation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecobionics Studies | Fecobionics: Fecobionics is a new device for studying defecation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 11 LARS patients | Posted | Mean | Standard Error | cmH2O | baseline and following intervention, approximately 30 seconds |
|
|
9 months
Same definitions as the clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fecobionics Studies | Fecobionics: Fecobionics is a new device for studying defecation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kaori Futaba | The Chinese University of Hong Kong, Department of Surgery, Prince of Wales Hospital | 0085264630121 | kfutaba@surgery.cuhk.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2020 | Aug 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Patients attending the colorectal functional clinic Prince of Wales Hospital in Hong Kong for management of severe low anterior resection syndrome post anterior resection for treatment of rectal cancer were invited to join this exploratory study. | Count of Participants | Participants |
|
| LARS score | The Low anterior resection syndrome score system was based on the published paper(Katrine J Emmertsen & Laurberg, 2012). The range of the score (0-42) was divided into groups of 0 to 20 (no LARS), 21 to 29 (minor LARS), and 30 to 42 (major LARS). | Median | Inter-Quartile Range | units on a scale |
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| 0 |
| 12 |
| 1 |
| 12 |
| 0 |
| 12 |
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