UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042664 |
|---|---|
| Receipt number | R000048679 |
| Scientific Title | Indwelling urinary catheters may increase the risk of postoperative altered mental status and urinary tract infection in patients undergoing less invasive surgery: A retrospective cohort study |
| Date of disclosure of the study information | 2020/12/06 |
| Last modified on | 2021/03/26 11:11:31 |
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Basic information
Public title
Indwelling urinary catheters in low-invasive surgery patients
Acronym
Indwelling urinary catheters in low-invasive surgery patients
Scientific Title
Indwelling urinary catheters may increase the risk of postoperative altered mental status and urinary tract infection in patients undergoing less invasive surgery: A retrospective cohort study
Scientific Title:Acronym
Indwelling urinary catheters in low-invasive surgery patients
Region
| Japan |
Condition
Condition
Diseases which were needed low-invasive surgery for treatment
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although indwelling urinary catheters (IUCs) are used intraoperatively and may cause complications (e.g., delirium), only few robust studies have investigated the association between intraoperative IUCs and complications. We hypothesized that IUC use might increase postoperative incidences of altered mental status or urinary catheter infection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
the incidence of altered mental status and/or urinary tract infection.
Key secondary outcomes
the length of postoperative hospital stay and AKI incidence after surgery.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We included all adult (18 years older) non-cardiac surgical patients who required general anesthesia between January 1, 2013, and December 31, 2018.
Key exclusion criteria
We excluded patients as follows: patients for whom we suppose to need IUC on surgery (to assess the urine output as an indicator for the optimal blood pressure, emergency, mechanical ventilation before surgery, carotid endarterectomy, for urine drainage, urology, traumatic spinal cord injury, epidural catheter use, spinal anesthesia, severe motor, or intellectual disabilities), patients undergoing neurosurgery affecting postoperative consciousness and immobility (craniotomy, trepanation, intracranial endovascular therapy), patients who could not speak and who could not vocalize strange words (tracheostomy), patients with chronic hemodialysis due to reduced urine output, and patients with cardiac arrest before surgery.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | TOKO |
| Middle name | Fukushima |
| Last name | FUKUSHIMA |
Organization
Tokyo Jikei University Katsushika Medical Center
Division name
Department of Anesthesiology
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo-to, Japan
TEL
0334331111
j.toko.fukushima105@gmail.com
Public contact
Name of contact person
| 1st name | TOKO |
| Middle name | Fukushima |
| Last name | FUKUSHIMA |
Organization
Jikei University of Medicine Katsushika medicalcenter
Division name
Department of Anesthesiology
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo-to, 125-8506, Japan
TEL
03-3603-2111
Homepage URL
j.toko.fukushima105@gmail.com
Sponsor or person
Institute
Jikei University of Medicine Katsushika medical center Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Jikei University of Medicine Katsushika medical center Department of Anesthesiology
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
Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461
Tel
03334331111
rinri@jikei.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
東京慈恵会医科大学葛飾医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2049080121001369?via%3Dihub
Number of participants that the trial has enrolled
14284
Results
We analyzed 5112 patients (control group, 2249 patients [44.0%]; IUC group, 2,863 patients [56.0%]). The prevalence of postoperative altered mental status and postoperative urinary catheter infection were 3.56% and 0.04%, respectively. After inverse propensity weighting, all baseline characteristics were similar between the two groups. However, patients with IUCs had a higher risk of postoperative complications (adjusted odds ratio, 1.97; 95% confidence interval [CI], 1.50-2.59).
Results date posted
| 2020 | Year | 12 | Month | 05 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 01 | Day |
Other
Other related information
This retrospective cohort study was conducted using the opt-out method of the hospital website. Before we accessed the data, we posted a document approved by the hospital's ethics committee on the website to provide an opportunity to reject the use of personal information. This study was conducted following the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) and STROCSS (Strengthening the Reporting of Cohort Studies in Surgery) statements.
Management information
Registered date
| 2020 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048679
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/12/25 | 周術期尿道カテーテル計画書第3版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/12/25 | 周術期尿道カテーテル統計解析計画書第3版.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/12/25 | Data_UrinaryCatheter.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/48679
