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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name