UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033002 |
|---|---|
| Receipt number | R000037624 |
| Scientific Title | Efficacy and safety of reduced port surgery for Colorectal cancer |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2020/12/18 12:19:57 |
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Basic information
Public title
Efficacy and safety of reduced port surgery for Colorectal cancer
Acronym
Efficacy and safety of RPS for CRC
Scientific Title
Efficacy and safety of reduced port surgery for Colorectal cancer
Scientific Title:Acronym
Efficacy and safety of RPS for CRC
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of reduced port surgery for colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of adverse event in postoperative 1 month or less
Key secondary outcomes
Short-term results (amount of blood loss, operative time, and duration of postoperative hospital stay)
Health related QOL score
Long-term results (5-year over-all survival rate and 5-year relapse-free survival rate)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard procedure with 4-5 access ports in laparoscopic colorectal cancer excision
Interventions/Control_2
Reduced-port surgery with 1-2 access ports in laparoscopic colorectal cancer excision
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
1) Histological proven colorectal carcinoma, clinical stage 0-III
2) Radical cure resection with D2-D3 lymph node dissection is scheduled.
3) Tumor location; Cecum, Ascending colon, Transverse colon, Descending colon, Sigmoid colon and Rectosigmoid colon
4) Tumor diameter is 5.0cm or smaller
5) 20 years old or more
6) Performance Status (ECOG); 0-1
7) No severe dysfunction of internal organs (Fill everything the following with the inspection within 14 days before registration)
White blood cell count > 2,000/mm3 and < 20,000/ mm3
Platelet number > 50,000/ mm3
Haemoglobin > 8.0 g/dl
AST(GOT) ALT(GPT) < 5 times of facilities standard value upper bound
Serum total bilirubin < 3.0 mg/dl
Serum creatinine < 3.0 mg/dl
8) Patient who is obtaining agreement by explanation document
Key exclusion criteria
1) Severe hypersensitivity
2) Synchronous or metachronous (within 5 years) malignancy other han carcinoma in situ
3) Active infectious disease
4) Severe mental disease
5) Pregnant or lactating women
6) Severe dysfunction of internal organs
7) History of the organ transplantation
8) Preoperative therapy (chemotherapy, radiotherapy and and hormonal therapy, etc.)
9) Improper patient for clinical trial
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Fujii |
Organization
Koga Community Hospital
Division name
Surgery
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu city, Shizuoka, Japan
TEL
054-628-5500
s_fujii631011@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Watanabe |
Organization
Koga Community Hospital
Division name
Division of medical technology
Zip code
425-0088
Address
2-30-1 Daikakuji, Yaizu city, Shizuoka, Japan
TEL
054-628-5500
Homepage URL
http://www.sunkohkai.or.jp/
ku7fk7se@i.softbank.jp
Sponsor or person
Institute
Koga Community Hospital
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Koga Community Hospital
Division of general affairs
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Teikyo University, Department of Surgery
International University of Health and Welfare, Ichikawa hospital, Department of Gastroenterological surgery
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Koga Community Hospital, Ethics committee
Address
2-30-1 Daikakuji, Yaizu city, Shizuoka, Japan
Tel
054-628-5500
ku7fk7se@i.softbank.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Teirin14-021
Org. issuing International ID_1
Teikyo University, Ethics committee
Study ID_2
33
Org. issuing International ID_2
International University of Health and Welfare, Ichikawa hospital, Ethics committee
IND to MHLW
Institutions
Institutions
コミュニティーホスピタル駿甲会甲賀病院（静岡県）、国際医療福祉大学市川病院（千葉県）、帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.sunkohkai.or.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.sunkohkai.or.jp/
Number of participants that the trial has enrolled
90
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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037624
