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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035144
Receipt No. R000040061
Scientific Title A Prospective, Non-randomized, Multicenter Study of the Efficacy of Adhesion Barriers in Laparoscopic Surgery for Colorectal Cancer in Japan
Date of disclosure of the study information 2018/12/17
Last modified on 2019/04/13

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Basic information
Public title A Prospective, Non-randomized, Multicenter Study of the Efficacy of Adhesion Barriers in Laparoscopic Surgery for Colorectal Cancer in Japan
Acronym SETOUCHI Study
Scientific Title A Prospective, Non-randomized, Multicenter Study of the Efficacy of Adhesion Barriers in Laparoscopic Surgery for Colorectal Cancer in Japan
Scientific Title:Acronym SETOUCHI Study
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to examine efficacy of adhesion barriers in laparoscopic surgery for colorectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of Incidence of adhesion-related complications observed in patients without adhesion prevention material with that of patients with adhesion prevention materials.
Key secondary outcomes 1) incidence of adhesion-related complications between anti-adhesion materials.
2) incidence of adhesion-related complications by adhesion preventing material spraying sites.
3) postoperative recurrence rate, relapse-free survival and overall survival of Stage II / III colorectal cancer after curative resection.
4) incidence of adhesion-related complications, postoperative recurrence rate, relapse-free survival , and overall survival of Stage II / III colorectal cancer after curative resection stratified by somatic mutation in colorectal cancer.

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 1) Patients who are planned to laparoscopic resection of colorectal cancer.
2) PS: 0 to 2 (ECOG performance status score).
3) Patients who can agree to join this study by written consent.
4) Patients judged to be able to survive for more than 1 year from the date of registration.
Key exclusion criteria 1) History of allergy for adhesion barriers
2) Cancerous ascites or peritoneal dissemination is observed on radiographic image
3) The attending physician deems inappropriate for participation in this study
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Tsuruta
Organization Kawasaki Medical School Hospital
Division name Department of Digestive Surgery
Zip code 701-0192
Address 577, Matsushima, Kutrashiki
TEL 086-462-1111
Email cheerupjean@icloud.com

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Nagasaka
Organization Kawasaki Medical School Hospital
Division name Department of Clinical Oncology
Zip code 701-0192
Address 577, Matsushima, Kutrashiki
TEL 086-462-1111
Homepage URL
Email takeshin@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Clinical Oncology, Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical School
Address 577, Matsushima, Kurashiki
Tel 086-462-1111
Email rinri@hp.kawasaki-m.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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 14 Day
Date of IRB
2019 Year 04 Month 09 Day
Anticipated trial start date
2019 Year 04 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is designed to examine efficacy of adhesion barriers in laparoscopic surgery for colorectal cancer.
Comparison of Incidence of adhesion-related complications observed in patients without adhesion prevention material with that of patients with adhesion prevention materials.

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2019 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040061

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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