UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035271 |
|---|---|
| Receipt number | R000040184 |
| Scientific Title | Validation of the Japanese Low Anterior Resection Syndrome(LARS) score as a self-administered questionnaire for postoperative bowel dysfunction after rectal cancer surgery: a multi-center prospective observational study |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2018/12/16 17:05:48 |
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Basic information
Public title
Validation of the Japanese Low Anterior Resection Syndrome(LARS) score as a self-administered questionnaire for postoperative bowel dysfunction after rectal cancer surgery: a multi-center prospective observational study
Acronym
Validation of the Japanese Low Anterior Resection Syndrome(LARS) score as a self-administered questionnaire for postoperative bowel dysfunction after rectal cancer surgery
Scientific Title
Validation of the Japanese Low Anterior Resection Syndrome(LARS) score as a self-administered questionnaire for postoperative bowel dysfunction after rectal cancer surgery: a multi-center prospective observational study
Scientific Title:Acronym
Validation of the Japanese Low Anterior Resection Syndrome(LARS) score as a self-administered questionnaire for postoperative bowel dysfunction after rectal cancer surgery
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validiate of the LARS score by comparing with conventional faecal incontinence scores and quality of life scores.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between the LARS score and conventional faecal incontinence scores, and quality of life scores.
Key secondary outcomes
Comparison with the jpLARSs, and the patient characteristics, surgical factors, and postoperative course
The collection rate and completion rate of the LARS score.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rectal cancer patients following curative sphincter-preserving surgery.
More than 1year has passed since surgery
Elder than 20years old
PS 1-2
The patient agreed to enter the study
Key exclusion criteria
Disseminated or recurrent disease
Presence of stoma less than 1 year after surgery or stoma closure
Aged<20 years
Patients with mental dementia
Any inability to participate in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Takemasa |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8556, Japan
TEL
011-611-2111(32810)
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emi Akizuki |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology
Zip code
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8556, 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
Department of Surgery, Surgical Oncology, Sapporo Medical University
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
Address
Tel
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
| 2018 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Multicenter prospective observational study
Management information
Registered date
| 2018 | Year | 12 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040184
