UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049106 |
|---|---|
| Receipt number | R000055944 |
| Scientific Title | Long-term outcomes of laparoscopic versus open colectomy for pathological T4 and/or N2 colon cancer patients: multicenter study using propensity-score matched analysis |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2022/10/04 08:05:07 |
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Basic information
Public title
Long-term outcomes of laparoscopic versus open colectomy for highly advanced colon cancer patients
Acronym
Laparoscopic colectomy for highly advanced cancer
Scientific Title
Long-term outcomes of laparoscopic versus open colectomy for pathological T4 and/or N2 colon cancer patients: multicenter study using propensity-score matched analysis
Scientific Title:Acronym
Laparoscopic colectomy for pT4/N2 cancer
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of overall survival after laparoscopic or open surgery for highly advanced colon cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
Non-metastatic patients with pT4 or pN2 colon cancers who underwent curative primary tumor resection between April 2016 and December 2020 at six hospitals (Ureshino Medical Center, Nagasaki University Hospital, Sasebo City General Hospital, Nagasaki Medical Center, Isahaya General Hospital and Saiseikai Nagasaki Hospital)
Key exclusion criteria
Patients with only stoma construction, emergency surgery, synchronous colon cancer, robotic surgery, and Stage IV disease
Target sample size
255
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagasaki University Hospital
Division name
Department of Surgical Oncology
Zip code
8528105
Address
1-7-1
TEL
0958197304
s.hashi12@outlook.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagasaki University Hospital
Division name
Surgical oncology
Zip code
852-8105
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
0958197304
Homepage URL
s.hashi12@outlook.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7
Tel
0958197304
s.hashi12@outlook.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
| 2022 | Year | 10 | Month | 04 | 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
255
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
| 2022 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compared the survival outcomes after laparoscopic or open surgery for colon cancer.
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055944
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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