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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044062
Receipt No. 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 2021/08/07

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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 over 65 years of age and undergoing scheduled laparotomy of more than 2 hours 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
Email 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
Email gasakinu@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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
2021 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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