UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046296 |
|---|---|
| Receipt number | R000052830 |
| Scientific Title | Elective colorectal cancer surgery in nonagenarians and postoperative outcomes |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2021/12/06 22:20:24 |
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Basic information
Public title
Elective colorectal cancer surgery in nonagenarians and postoperative outcomes
Acronym
Colorectal cancer surgery in nonagenarians
Scientific Title
Elective colorectal cancer surgery in nonagenarians and postoperative outcomes
Scientific Title:Acronym
Colorectal cancer surgery in nonagenarians
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the postoperative outcomes of nonagenarians in the latest clinical settings
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive factor of the postoperative complications and 90-day mortality
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
| 90 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Included in this study were consecutive patients aged over 90 years for whom elective colorectal cancer surgery was planned between January 2018 and December 2020
Key exclusion criteria
Not applicable
Target sample size
81
Research contact person
Name of lead principal investigator
| 1st name | Mikihito |
| Middle name | |
| Last name | Nakamori |
Organization
National Hospital Organization Osaka Minami Medical Center
Division name
Department of Surgery
Zip code
586-8521
Address
2-1, Kidohigashicho, Kawachinagano 586-8521, Osaka, Japan
TEL
0721535761
tamukoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Tamura |
Organization
National Hospital Organization Osaka Minami Medical Center
Division name
Department of Surgery
Zip code
586-8521
Address
2-1, Kidohigashicho, Kawachinagano 586-8521, Osaka, Japan
TEL
0721535761
Homepage URL
tamukoh@wakayama-med.ac.jp
Sponsor or person
Institute
Clinical Research Center, National Hospital Organization Osaka Minami Medical Center
Institute
Department
Personal name
Funding Source
Organization
self-sustaining
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
Clinical Research Center, National Hospital Organization Osaka Minami Medical Center
Address
2-1, Kidohigashicho, Kawachinagano 586-8521, Osaka, Japan
Tel
0721535761
tamukoh@wakayama-med.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
| 2021 | Year | 12 | Month | 07 | 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
81
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
| 2021 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, gender, body mass index, comorbidity (history of cerebrovascular disease, chronic respiratory disease, myocardial disease, orthopedic lower limb disease, hypertension, diabetes mellitus, use of anticoagulant agent, and past history of malignancy), American Society of Anesthesiologists score, and Eastern Cognitive Oncology Group performance status score. We also retrieved other variables of preoperative biochemical blood examination (hemoglobin, serum concentration of albumin, and peripheral lymphocyte count), surgical findings (operation time, blood loss, history of laparotomy, tumor location, laparoscopic vs. open approach, and stoma creation), and postoperative factors (surgical complications within 30 days including Common Terminology Criteria for Adverse Events v5.0 [CTCAE] classification, delirium, and final staging following the recent American Joint Committee on Cancer TNM staging system).
Management information
Registered date
| 2021 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052830
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/12 | Nonagenarian_retrospective_CRC_protocol_OMMC_KiCSē”.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/12 | Nonagenarian_CRF_OMMC.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/12 | Nonagenarian_CRF_OMMC_20210810.xlsx |
