UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046633 |
|---|---|
| Receipt number | R000053198 |
| Scientific Title | Remote rehabilitation program for preoperative gastrointestinal cancer patient |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/01/14 02:18:02 |
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Basic information
Public title
Remote rehabilitation program for preoperative gastrointestinal cancer patient
Acronym
Remote rehabilitation program for preoperative gastrointestinal cancer patient
Scientific Title
Remote rehabilitation program for preoperative gastrointestinal cancer patient
Scientific Title:Acronym
Remote rehabilitation program for preoperative gastrointestinal cancer patient
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the feasibility of a novel remote rehabilitation program for preoperative gastrointestinal cancer patient
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Feasibility of a novel remote rehabilitation program for preoperative gastrointestinal cancer patient
Key secondary outcomes
Postoperative complications and prognosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Remote rehabilitation program
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
preoperative gastrointestinal cancer patient
Key exclusion criteria
1) Severe heart failure
2) COPD
3) Low PS
4) Renal failure
5) Liver failure
6) Dementia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Yamatsuji |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Surgery
Zip code
700-8505
Address
2-6-1 Nakasange, Okayama
TEL
0862252111
yama-t@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Yamatsuji |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Surgery
Zip code
700-8505
Address
2-6-1 Nakasange, Okayama
TEL
0862252111
Homepage URL
yama-t@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of General Surgery,
Kawasaki Medical School General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of General Surgery,
Kawasaki Medical School General Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima,Kurashiki-City,Okayama
Tel
0862252111
yama-t@med.kawasaki-m.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
川崎医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053198
