UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040697 |
|---|---|
| Receipt number | R000046458 |
| Scientific Title | The psychology of patients before and after implentation biofeedback therapy after stoma closure surgery -Suevey on patients with ultra low anterior resection and intersphincteric resection- |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/12/22 17:54:08 |
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Basic information
Public title
The psychology of patients before and after implentation biofeedback therapy after stoma closure surgery
-Suevey on patients with ultra low anterior resection and intersphincteric resection-
Acronym
The psychology of patients before and after implentation biofeedback therapy after stoma closure surgery
-Suevey on patients with ultra low anterior resection and intersphincteric resection-
Scientific Title
The psychology of patients before and after implentation biofeedback therapy after stoma closure surgery
-Suevey on patients with ultra low anterior resection and intersphincteric resection-
Scientific Title:Acronym
The psychology of patients before and after implentation biofeedback therapy after stoma closure surgery
-Suevey on patients with ultra low anterior resection and intersphincteric resection-
Region
| Japan |
Condition
Condition
Stoma closure
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Targeting patients undergoing stoma closure after intersphincteric or ultra-low anterior resection, and conducting biofeedback therapy using anal electromyography to examine the psychology of the patient before and after implementation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Linguistic data related to psychological and perception of pelvic floor gymnastics generated by biofeedback therapy
Key secondary outcomes
anal sphincter function
Wexner Score
LARS Score
Modified Fecal incontinence Quality of Life Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conduct biofeedback therapy once a month for 3 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients under the age of 65 who underwent stoma closure after intersphincteric resection or ultra-low anterior resection at Sapporo Medical University Hospital
2)Those who are within 6 months after surgery at the start of biofeedback therapy
Key exclusion criteria
1)Those who have problems with movement of limbs due to cerebrovascular disease etc. and are using assistive devices
2)Persons with diseases that impede the implementation of pelvic floor muscle exercises
3)Those who have symptoms during exercise due to cardiovascular disease
4)Person diagnosed with dementia
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shigeyuki |
| Middle name | |
| Last name | Saito |
Organization
Sapporo Medical University
Division name
Department of nursing, Third course
Zip code
060-0061
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku,Sapporo-shi,Hokkaidou
TEL
011-611-2111
ssaitoh@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Nakano |
Organization
Sapporo Medical University
Division name
Department of Nursing, Graduate School of Health Sciences
Zip code
060-0061
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku,Sapporo-shi,Hokkaido
TEL
011-611-2111
Homepage URL
kaori_0824_ch@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Department of Nursing, Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Department of Nursing, Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
IRB Contact (For public release)
Organization
Sapporo Medical University Institutional Review Board
Address
291, Minami 1-jo Nishi 16-chome, Chuo-ku,Sapporo-shi,Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://
Publication of results
Unpublished
Result
URL related to results and publications
https://
Number of participants that the trial has enrolled
5
Results
The study showed that visually understanding the contraction of the anal sphincter by the BF may help patients restore their sense of ability to perform contractions. Further, it was found that the feeling of recovery of the anal sphincter function by the BF affects the increased motivation toward performing exercises such as pelvic floor muscle exercises, and this is again related to the feeling of improvement in muscle strength due to the exercises.
Results date posted
| 2021 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
The study participants were five male patients, aged 53.8 years. For the types of rectal resection, four participants underwent inter-sphincter resection and one super-low anterior resection.
Participant flow
We provided biofeedback interventions once a month for three months for five patients who underwent stoma closure after inter-sphincter resection or super-low anterior resection. Semi-structured interviews were conducted before and after the BF to collect data on the psychological effects of defecation disorder and the psychology caused by the BF. A qualitative descriptive analysis identified codes from the interview data, and subcategories and categories were created.
Adverse events
Nothing
Outcome measures
Semi-structured interviews were conducted before and after the BF to collect data on the psychological effects of defecation disorder and the psychology caused by the BF. A qualitative descriptive analysis identified codes from the interview data, and subcategories and categories were created. Further, we obtained the results of the anorectal manometry from the electronic medical records of the participants and administered a questionnaire yielding a Low Anterior Resection Syndrome (LARS) Score that shows their severity of the defecation disorder. T
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046458
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