UMIN-CTR Clinical Trial

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
Email	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
Email	kaori_0824_ch@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University Department of Nursing, Graduate School of Health Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046458