UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Ichiro Takemasa
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology
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	Emi Akizuki
Organization	Sapporo Medical University
Division name	Department of Surgery, Surgical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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