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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021752
Receipt No. R000025083
Scientific Title Questionnaire for cosmetic outcomes in laparoscopic colectomy
Date of disclosure of the study information 2016/04/02
Last modified on 2016/07/21

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Basic information
Public title Questionnaire for cosmetic outcomes in laparoscopic colectomy
Acronym Questionnaire for cosmetic outcomes
Scientific Title Questionnaire for cosmetic outcomes in laparoscopic colectomy
Scientific Title:Acronym Questionnaire for cosmetic outcomes
Region
Japan

Condition
Condition colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the cosmetic outcomes of single-site laparoscopic colectomy (SLC) compared to conventional multiport laparoscopic colectomy (MLC) for colon cancer.
Basic objectives2 Others
Basic objectives -Others To assess the difference of consciousness for cosmetic outcomes between people in general and medical workers.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degree of bodily injury, self-consciousness and distress was evaluated using the VAS scale for comparison of SLC versus MLC.
Key secondary outcomes Points for curability, safety, cosmetic outcomes, pain and hospitalization in colectomy for colon cancer will be given by people in general to assess the importance of cosmetic outcomes.

Base
Study type Others,meta-analysis etc

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
90 years-old >
Gender Male and Female
Key inclusion criteria At least 30 males and 30 females in each age group are required for statistical analyses. Therefore a total of more than 500 people will be collected.
Key exclusion criteria There is no exclusion criteria.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Mori
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 2-2, E-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email mmori@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Takemasa
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address S-1, W-17, Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-611-2111
Homepage URL
Email itakemasa@sapmed.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization National Hospital Organization Osaka National Hospital
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
2016 Year 04 Month 02 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 Preinitiation
Date of protocol fixation
2015 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After the collection of cases, the questionnaire will be conducted.

Management information
Registered date
2016 Year 04 Month 02 Day
Last modified on
2016 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025083

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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