UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054370 |
|---|---|
| Receipt number | R000062082 |
| Scientific Title | Perioperative rehabilitation and nutritional assessment of respiratory surgery patients and its impact on postoperative physical recovery, surgical safety and prognosis. |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2024/05/10 20:18:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perioperative rehabilitation and nutritional assessment of respiratory surgery patients and its impact on postoperative physical recovery, surgical safety and prognosis.
Acronym
Perioperative rehabilitation and nutritional assessment of respiratory surgery patients and its impact on postoperative physical recovery, surgical safety and prognosis.
Scientific Title
Perioperative rehabilitation and nutritional assessment of respiratory surgery patients and its impact on postoperative physical recovery, surgical safety and prognosis.
Scientific Title:Acronym
Perioperative rehabilitation and nutritional assessment of respiratory surgery patients and its impact on postoperative physical recovery, surgical safety and prognosis.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Rehabilitation medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the improvement in surgical safety and the correlation between each factor and prognosis in the perioperative period of lung cancer when a multidisciplinary and multidisciplinary team is involved in the perioperative management of respiratory surgery. To analyse how nutritional indices measured in the nutrition department and physical assessment indices measured in the rehabilitation department change and recover throughout the perioperative period. The study will be conducted using a prospective database of usual rehabilitation and nutritional assessment items that are calculated by insurance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between preoperative rehabilitation measures and nutritional indices and postoperative complications.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
(i) Determination of respiratory surgery based on surgical tolerance and clinical staging, and consent to participate in the plan.
(ii) Outpatient rehabilitation and nutritional counselling
(iii) Respiratory function, physical function, oxygenation assessment and ADL assessment by physiotherapist
(iv) Nutritional assessment and counselling by dietician
(v) Body composition assessment
Outpatient - post-hospitalisation rehabilitation
Pre-operative outpatient - home rehabilitation planning
(viii) Carrying out respiratory surgery
(ix) Post-operative rehabilitation
(10) Assessment of complications on discharge and discharge counselling
(11) Assessment of complications at 30 days post-operatively
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients aged 60 years and over who underwent rehabilitation prior to respiratory surgery.
(ii) Patients who have given a full explanation of their participation in the study and have given written consent of their own free will.
Key exclusion criteria
(i) Cases in which the patient's cooperation for rehabilitation was not obtained.
(ii) Cases in which consent to participate in the study could not be obtained.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Uehara |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Thoracic Surgery
Zip code
040-8611
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan, 040-8611
TEL
0138512295
hirofumiuehara113@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Uehara |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Thoracic Surgery,
Zip code
040-8611
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan, 040-8611
TEL
0138512295
Homepage URL
hirofumiuehara113@gmail.com
Sponsor or person
Institute
Hakodate Goryoukaku Hospital
Institute
Department
Personal name
Funding Source
Organization
Hakodate Goryoukaku Hospital
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
Hakodate Goryoukaku Hospital
Address
38-3 Goryokaku-cho, Hakodate, Hokkaido Japan
Tel
0138512295
hirofumiuehara113@gmail.com
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
| 2024 | Year | 05 | Month | 10 | 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
200
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
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062082
