UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035144 |
|---|---|
| Receipt number | 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 | 2023/09/06 16:43:32 |
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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
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
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Kawasaki Medical School
Institute
Department
Personal name
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
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
452
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
No longer recruiting
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
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040061
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/12/11 | 3366-03様式8（2021.6-1版）研究計画書（一般用）.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
