Anterior Resection Syndrome, Bowel Dysfunction
Conditions
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.
Interventions
DEVICEFecobionics
Fecobionics is a new device for studying defecation
Sponsors
Giome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Anorectal Pressure Assessed With the Fecobionics Device | baseline and following intervention, approximately 30 seconds | 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. |
Countries
Hong Kong
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fecobionics Studies Fecobionics: Fecobionics is a new device for studying defecation | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Fecobionics Studies |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| LARS score | 39 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Hong Kong | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
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.
Time frame: baseline and following intervention, approximately 30 seconds
Population: 11 LARS patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fecobionics Studies | Change of Anorectal Pressure Assessed With the Fecobionics Device | 9.8 cmH2O | Standard Error 2.1 |