UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046527 |
|---|---|
| Receipt number | R000053081 |
| Scientific Title | A prospective observational study of preoperative bio-feedback therapy to prevent Low Anterior Resection Syndrome (LARS) following rectal surgery |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2025/01/07 15:33:24 |
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Basic information
Public title
A prospective observational study of preoperative bio-feedback therapy to prevent Low Anterior Resection Syndrome (LARS) following rectal surgery
Acronym
A prospective observational study of preoperative bio-feedback therapy
Scientific Title
A prospective observational study of preoperative bio-feedback therapy to prevent Low Anterior Resection Syndrome (LARS) following rectal surgery
Scientific Title:Acronym
A prospective observational study of preoperative bio-feedback therapy
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of preoperative Biofeedback Rehabilitation (BFR) in reducing Low Anterior Resection Syndrome (LARS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of severe LARS six months after ileal stoma closure
Key secondary outcomes
Anal pressure, State of fecal disorder (LARS score, Wexner score), State of QoL (mFIQL, SF36)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo SPS with temporary ileal fistula for lower rectal cancer and meet the following conditions
1) Have undergone preoperative BFR
2) Patient who is able to continue rehabilitation at home.
(3) Patient who is able to continue outpatient visits after surgery
4) Written consent for participation has been obtained.
Key exclusion criteria
In case the doctor considered the patient inappropriate to attempt the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
011-611-2111(32810)
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Akizuki |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
011-611-2111(32810)
Homepage URL
akizuki@sapmed.ac.jp
Sponsor or person
Institute
Department of Surgery, Surgical Oncology, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Hospital, Institutional Review Board
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543, Japan
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Preoperative and postoperative defecation status, QoL, intra-anal pressure, rate of learning preoperative BFR, rate of performing home rehabilitation, etc. will be obtained during outpatient visits.
Management information
Registered date
| 2022 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053081
