UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051051 |
|---|---|
| Receipt number | R000058209 |
| Scientific Title | Sacral Surgery-Related Pressure Injury and Shear Stress due to operating table rotation in the lithotomy position; Prospective observational study |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/06/11 16:41:57 |
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Basic information
Public title
Sacral Surgery-Related Pressure Injury and Shear Stress due to operating table rotation in the lithotomy position; Prospective observational study
Acronym
Sacral Surgery-Related Pressure Injury and Shear Stress due to operating table rotation in the lithotomy position; Prospective observational study
Scientific Title
Sacral Surgery-Related Pressure Injury and Shear Stress due to operating table rotation in the lithotomy position; Prospective observational study
Scientific Title:Acronym
Sacral Surgical-Related Pressure Injury and Shear Stress study
Region
| Japan |
Condition
Condition
surgery-related pressure injury
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the impact of shear stress on surgery-related PI in the sacral region after laparoscopic colorectal resection performed in the lithotomy position.
Basic objectives2
Others
Basic objectives -Others
Investigation the impact of shear stress on surgery-related pressure injury in the sacral region
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the average horizontal shear stress during the operation
Key secondary outcomes
the direction for horizontal pressure in the sacral region, the change over time in horizontal shear stress and the interface pressure in the sacral region
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
all patients who underwent laparoscopic colorectal resection surgery in lithotomy position
Key exclusion criteria
loop colostomy, which does not require rotation of the operating table, and total proctocolectomy, which requires various directions or angles of rotation of the operating table in a single surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Kurachi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2279
kurachi1@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyota |
| Middle name | |
| Last name | Tatsuta |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2279
Homepage URL
kyota420@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Center for Clinical Research
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2850
bayashi@hama-med.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
| 2023 | Year | 05 | Month | 15 | 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
37
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
| 2021 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 05 | Month | 08 | Day |
Other
Other related information
Study Design and patient population
This prospective cohort study recruited and enrolled all patients who underwent laparoscopic colorectal resection surgery in lithotomy position between November 2021 and October 2022.
Procedures
Pressure and shear force sensors were used to measure the horizontal and interfacial pressures in the sacral region. The tilt was 15 in the lowerhead position and 15 in the lowerright position, and the position was continued for 120 min. The recording time was defined as the time from the start of surgery to bowel resection to minimize getting the sensor soiled by the surgical procedure.
Definition of PI in the sacral region
Patients with skin redness were defined as the PI group. The PI group included patients with pressure ulcers,non-blanchable redness, and reactive hyperemia,blanchable redness. Pressure ulcer was classified based on the National Pressure Ulcer Advisory Panel.
Management information
Registered date
| 2023 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058209
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