UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052347 |
|---|---|
| Receipt number | R000059760 |
| Scientific Title | A retrospective study on oral rehydration solution intake during preoperative oral rehydration therapy |
| Date of disclosure of the study information | 2023/09/29 |
| Last modified on | 2024/12/09 16:11:56 |
* 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
A retrospective study on oral rehydration solution intake during preoperative oral rehydration therapy
Acronym
A retrospective study on oral rehydration solution intake during preoperative oral rehydration therapy
Scientific Title
A retrospective study on oral rehydration solution intake during preoperative oral rehydration therapy
Scientific Title:Acronym
A retrospective study on oral rehydration solution intake during preoperative oral rehydration therapy
Region
| Japan |
Condition
Condition
Surgery in general
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate preoperative ORS intake from medical information of cases undergoing PO-ORT.
For cases of inadequate intake, we will clarify the cause based on the patient's background and consider improvement measures.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors leading to insufficient preoperative oral rehydration intake
Key secondary outcomes
Relationship between preoperative oral rehydration intake and intraoperative blood pressure reduction
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Subjects aged over 20
(2)Patients scheduled for surgery
(3)Subjects with American Society of Anesthesiologists physical status (ASA-PS) I or II
(4)Patients drunk OS-1
Key exclusion criteria
(1)Subjects with dementia or Parkinson's disease
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
taniguchihideki@outlook.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Taniguchi |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Department of Patient Support Center
Zip code
230-8765
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
TEL
045-576-3000
Homepage URL
taniguchihideki@outlook.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Hideki Taniguchi
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Tobu Hospital Institutional Review Board
Address
3-6-1 Shimosueyoshi Tsurumiku Yokohamashi Kanagawa
Tel
045-576-3000
k_harita@tobu.saiseikai.or.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
済生会横浜市東部病院（神奈川県）
Saiseikai Yokohamashi Tobu Hosptital, Kanagawa
神奈川県立がんセンター（神奈川県）
Kanagawa Cancer Center
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 29 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059760
