UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000002753 |
| Receipt No. | R000003321 |
| Scientific Title | Predicting risk of postoperative pulmonary complications with history and physical examination |
| Date of disclosure of the study information | 2009/11/16 |
| Last modified on | 2020/08/09 (Ver. 8) |
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| Basic information | ||
| Public title | Predicting risk of postoperative pulmonary complications with history and physical examination | |
| Acronym | Predicting risk of postoperative pulmonary complications | |
| Scientific Title | Predicting risk of postoperative pulmonary complications with history and physical examination | |
| Scientific Title:Acronym | Predicting risk of postoperative pulmonary complications | |
| Region |
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| Condition | |||
| Condition | Elective abdominal surgery | ||
| Classification by specialty |
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| Classification by malignancy | Others | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | To validate history and physical examination are equally or more predictive of pulmonary complications than pulmonary function tests. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Morbidity of postoperative pulmonary complications |
| Key secondary outcomes | |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
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| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
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| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Patients who undergo elective abdominal surgery under general anesthesia at Jichi Medical University Hospital | |||
| Key exclusion criteria | None | |||
| Target sample size | 1000 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Jichi Medical University | ||||||
| Division name | Surgery | ||||||
| Zip code | 329-0498 | ||||||
| Address | 3311-1 Yakushiji, Shimotsuke, Tochigi | ||||||
| TEL | 81+285587371 | ||||||
| alefor@jichi.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Jichi Medical University | ||||||
| Division name | Surgery | ||||||
| Zip code | 329-0498 | ||||||
| Address | 3311-1 Yakushiji, Shimotsuke, Tochigi | ||||||
| TEL | 81+285587371 | ||||||
| Homepage URL | |||||||
| froyokota@hotmail.com | |||||||
| Sponsor | |
| Institute | Department of Surgery, Jichi Medical University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Jichi Medical University |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Jichi Medical University |
| Address | 3311-1Yakushiji Shimotsuke |
| Tel | 0285-44-2100 |
| rinri@jichi.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 | 自治医科大学附属病院（栃木県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 | ||||||
| Number of participants that the trial has enrolled | 676 | ||||||
| Results | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 |
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| Participant flow | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 |
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| Adverse events | None |
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| Outcome measures | PMID: 31809807 DOI: 10.1016/j.ijsu.2019.11.032 |
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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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| Date analysis concluded |
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| Other | |
| Other related information | Yokota S, Koizumi M, Togashi K, et al. Preoperative pulmonary function tests do not predict the development of pulmonary complications after elective major abdominal surgery: A prospective cohort study. Int J Surg. 2020;73:65-71. doi:10.1016/j.ijsu.2019.11.032 |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003321 |
