UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000024660 |
| Receipt No. | R000027373 |
| Scientific Title | the relationship between VATS and postoperative quality of life |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2019/11/03 (Ver. 7) |
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| Basic information | ||
| Public title | the relationship between VATS and postoperative quality of life | |
| Acronym | VATS and postoperative quality of life | |
| Scientific Title | the relationship between VATS and postoperative quality of life | |
| Scientific Title:Acronym | VATS and postoperative quality of life | |
| Region |
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| Condition | ||||
| Condition | the patients undergoing VATS lobectomy | |||
| Classification by specialty |
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| Classification by malignancy | Malignancy | |||
| Genomic information | NO | |||
| Objectives | |
| Narrative objectives1 | to identify chronic pain and life function |
| Basic objectives2 | Others |
| Basic objectives -Others | the relationship of daily life |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | QOR 40 chronic pain |
| Key secondary outcomes | SF8 TMIG Index WHODAS sleep index |
| 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 |
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| Interventions/Control_1 | Questionnaire
Actigraph |
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| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | elective VATS lobectomy under general anesthesia
Seven or more days of hospitalization is expected |
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| Key exclusion criteria | post VATS surgery patients
use of sedatives Patient with mental illness or neuropathy Patient preoperative evaluation is difficult |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Nara Medical University | ||||||
| Division name | Anesthesiology | ||||||
| Zip code | 6348521 | ||||||
| Address | 840 Shijo-cho, Kashihara, Nara 634-8522, Japan | ||||||
| TEL | 09079627114 | ||||||
| nwnh0131@yahoo.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Nara Medical University | ||||||
| Division name | Anesthesiology | ||||||
| Zip code | 6348521 | ||||||
| Address | 840 Shijo-cho, Kashihara, Nara 634-8522, Japan | ||||||
| TEL | 0744-22-3051 | ||||||
| Homepage URL | |||||||
| nwnh0131@yahoo.co.jp | |||||||
| Sponsor | |
| Institute | Nara Medical University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | non |
| 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 | Nara Medical University |
| Address | Kashihara shijo 840 |
| Tel | 09079627114 |
| nwnh0131@yahoo.co.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 |
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| Related information | |
| URL releasing protocol | www |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | www | ||||||
| Number of participants that the trial has enrolled | 24 | ||||||
| Results | Refer to publication |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Refer to publicatipn |
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| Participant flow | Refer to publicatipn |
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| Adverse events | Refer to publicatipn |
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| Outcome measures | Refer to publicatipn |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027373 |
