UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043991 |
|---|---|
| Receipt number | R000050240 |
| Scientific Title | The Usefulness of Perioperative Pelvic Floor Muscle Training for Postoperative Bowel Dysfunction after Low Anterior Resection: Aim for a good defecation environment |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2022/04/22 12:04:38 |
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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
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
kyota420@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050240
