UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042676 |
|---|---|
| Receipt number | R000048697 |
| Scientific Title | Laparoscopic versus open surgery for advanced mid transverse colon cancer: A multi center study |
| Date of disclosure of the study information | 2020/12/07 |
| Last modified on | 2023/10/26 18:19:29 |
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Basic information
Public title
Laparoscopic versus open surgery for advanced mid transverse colon cancer: A multi center study
Acronym
Laparoscopic versus open surgery for advanced mid transverse colon cancer: A multi center study
Scientific Title
Laparoscopic versus open surgery for advanced mid transverse colon cancer: A multi center study
Scientific Title:Acronym
Laparoscopic versus open surgery for advanced mid transverse colon cancer: A multi center study
Region
| Japan |
Condition
Condition
Advanced mid transverse colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of laparoscopic surgery for advanced mid transverse colon cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative complications
Key secondary outcomes
Overall survival
Recurrence free survival
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. pStageII/III (UICC TNM 8th)
2. Mid transverse colon cancer
3. Patients underwent colectomy between Jan,2008 and Dec,2019
Key exclusion criteria
1. Patients underwent extended left colectomy or left colectomy
2. Patients underwent the other surgical procedure
3. Double cancer
4. Colitic cancer
5. Emergency surgery due to cancer ileus
6. Past history of colectomy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shiozawa |
| Middle name | |
| Last name | Manabu |
Organization
Kanagawa cancer center
Division name
Department of colorectal surgery
Zip code
241-5815
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
TEL
0455202222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Iguchi |
| Middle name | |
| Last name | Kenta |
Organization
Kanagawa cancer center
Division name
Department of colorectal surgery
Zip code
241-5815
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
TEL
0455202222
Homepage URL
igcknt0802@gmail.com
Sponsor or person
Institute
Kanagawa cancer center
Institute
Department
Personal name
Funding Source
Organization
None
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
Kanagawa cancer center
Address
2-3-2, Nakao, Asahi-ku, Yokohama-shi, Kanagawa-ken
Tel
0455202222
igcknt0802@gmail.com
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
| 2020 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
177
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 06 | Month | 09 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
