UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044062 |
|---|---|
| Receipt number | R000049728 |
| Scientific Title | The impact of quality of recovery on postoperative functional disability |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/05/26 13:12:02 |
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Basic information
Public title
The impact of quality of recovery on postoperative functional disability
Acronym
The impact of quality of recovery on postoperative functional disability
Scientific Title
The impact of quality of recovery on postoperative functional disability
Scientific Title:Acronym
The impact of quality of recovery on postoperative functional disability
Region
| Japan |
Condition
Condition
abdominal malignant tumor
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure quality of recovery and function of life for surgery for malignant tumors in the elderly and to investigate whether low postoperative recovery is associated with impaired function of life.
Basic objectives2
Others
Basic objectives -Others
Causal relationship between quality of recovery and life function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the relationship between recovery (QoR-15) on postoperative day 4 and function of life (12-item version of WHODAS 2.0) 3 months after surgery.
Key secondary outcomes
To investigate the impact of preoperative frailty and nutritional status on postoperative recovery.
To evaluate the factors associated with postoperative recovery.
Perioperative grip strength should be evaluated.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 65 years of age or older and undergoing scheduled h abdominal surgery of 2 hours or more due to abdominal tumor.
Key exclusion criteria
Patients with motor paralysis due to neuromuscular disease or motor paralysis.
Patients who do not understand Japanese sufficiently (patients who require an interpreter for preoperative explanations).
Target sample size
252
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kinugasa |
Organization
Nara Medical University Hospital
Division name
Medical Technology Center
Zip code
634-8522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
gasakinu@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kinugasa |
Organization
Nara Medical University Hospital
Division name
Medical Technology Center
Zip code
634-8522
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
gasakinu@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nara Medical University Office of Medical Ethics Review Committee
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744-22-3051
ino_rinri@naramed-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The term "invasion" is defined as an injury or burden to the body or mind of a research subject (patient) caused by a puncture, incision, drug administration, irradiation, or traumatic questioning for the purpose of research, while "minor invasion" is defined as an invasion that causes little injury or burden to the body or mind of the research subject. In this study, preoperative and postoperative questionnaire surveys and grip strength measurements will be conducted. This act itself is not considered invasive, but since it is performed during the stressful period of the perioperative period, it was judged to be a minor invasion.
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049728
| 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 |
