UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026789 |
|---|---|
| Receipt number | R000030744 |
| Scientific Title | Additional survey for "open versus laparoscopic surgery for advanced low rectal cancer patients"study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2022/04/05 13:45:41 |
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Basic information
Public title
Additional survey for "open versus laparoscopic surgery for advanced low rectal cancer patients"study
Acronym
Additional survey for "open versus laparoscopic surgery for advanced low rectal cancer patients"study
Scientific Title
Additional survey for "open versus laparoscopic surgery for advanced low rectal cancer patients"study
Scientific Title:Acronym
Additional survey for "open versus laparoscopic surgery for advanced low rectal cancer patients"study
Region
| Japan |
Condition
Condition
Low rectal cancer
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term outcomes of laparoscopic and open surgery for stage II/III low rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients with clinical stage II/III low rectal cancer
2)patients who underwent primary rectal cancer resection
3)patients with preoperative radiation and/or chemotherapy are eligible
Key exclusion criteria
1)Patients with multiple primary cancers
2)Patients with treatment history for other pelvic malignancy
3)robotic surgery cases
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Sakai |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Hida |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
hidakoya@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japan Society of Laparoscopic Colorectal Surgery
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy, and The Japan Society of Clinical Oncology
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
Kyoto University Hospital Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
腹腔鏡下大腸切除研究会所属69施設
(Institutions of the Japan Society of Laparoscopic Colorectal Surgery)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1245/s10434-021-10312-7
Number of participants that the trial has enrolled
731
Results
Of a follow-up cohort of 1500 patients with low advanced rectal cancer, 731 patients with preoperative MR imaging were included. In patients with lateral lymph node short diameter between 5 mm and 10 mm, 5-year OS and RFS were significantly better in patients who underwent lateral lymph node dissection than in those who did not (OS: 81.9% vs. 67.3%; RFS: 69.4% vs. 51.6%). In multivariate analysis, lateral lymph node dissection was an independent factor contributing to survival.
Results date posted
| 2022 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
Five-year relapse-free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Multicenter retrospective study
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030744
| 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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