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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035271
Receipt No. 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

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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)
Email 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
Email akizuki@sapmed.ac.jp

Sponsor
Institute Department of Surgery, Surgical Oncology, Sapporo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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