UMIN-CTR Clinical Trial

Basic information
Public title	The Usefulness of Perioperative Pelvic Floor Muscle Training for Postoperative Bowel Dysfunction after Low Anterior Resection: Aim for a good defecation environment
Acronym	The Usefulness of Perioperative Pelvic Floor Muscle Training for Postoperative Bowel Dysfunction after Low Anterior Resection: Aim for a good defecation environment
Scientific Title	The Usefulness of Perioperative Pelvic Floor Muscle Training for Postoperative Bowel Dysfunction after Low Anterior Resection: Aim for a good defecation environment
Scientific Title:Acronym	The Usefulness of Perioperative Pelvic Floor Muscle Training for Postoperative Bowel Dysfunction after Low Anterior Resection: Aim for a good defecation environment
Region	Japan

Condition
Condition	rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the degree of dysbiosis in patients who have undergone radical resection for lower rectal cancer by using the rectoanal pressure test system with and without perioperative pelvic floor muscle taraining.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Percent change in maximum resting static pressure between 2 weeks before and 3 months after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Perioperative pelvic floor gymnastics intervention case
Interventions/Control_2	not perioperative pelvic floor gymnastics intervention case
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed with lower rectal cancer at the Department of Lower Gastrointestinal Surgery, Hamamatsu University School of Medicine Hospital, and are scheduled to undergo surgery under normal care between 2021 and February 2025. Patients who meet all of the following criteria and are judged to be appropriate for participation in this study will be eligible. 1. Patients who are judged to be able to continue pelvic floor muscle exercises. 2) Patients who are 20 years old or older. 3. Patients who have given their consent for this study by signing the consent form.
Key exclusion criteria	1. Patients who are scheduled to have a colostomy in addition to resection of the primary tumor. 2. Patients who will have difficulty in preserving anal function during the resection of the primary tumor. 3. Patients who have received preoperative treatment related to the primary tumor. 4. Patients with neuromuscular diseases. 5. Patients who have respiratory dysfunction and require preoperative respiratory rehabilitation. Women who are pregnant or may become pregnant. Women who are breastfeeding. 8. Persons deemed unsuitable by the principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kiyotaka Middle name Last name Kurachi
Organization	Hamamatsu University School of Medicine
Division name	Department of Surgery
Zip code	431-3192
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL	053-435-2279
Email	kurachi123@mac.com

Public contact
Name of contact person	1st name Kyota Middle name Last name Tatsuta
Organization	Hamamatsu University School of Medicine
Division name	Department of Surgery
Zip code	431-3192
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL	053-435-2279
Homepage URL
Email	kyota420@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel	053-435-2680
Email	bayashi@hama-med.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 04 Month 01 Day
Date of IRB	2021 Year 04 Month 15 Day
Anticipated trial start date	2021 Year 05 Month 10 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 21 Day
Last modified on	2022 Year 04 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050240