UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043892 |
|---|---|
| Receipt number | R000050124 |
| Scientific Title | Efficacy of preoperative swallowing screening for the elderly patients with gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2021/04/19 |
| Last modified on | 2023/10/13 14:30:28 |
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Basic information
Public title
Efficacy of preoperative swallowing screening for the elderly patients with gastrectomy for gastric cancer
Acronym
Efficacy of preoperative swallowing screening for the elderly patients with gastrectomy for gastric cancer
Scientific Title
Efficacy of preoperative swallowing screening for the elderly patients with gastrectomy for gastric cancer
Scientific Title:Acronym
Efficacy of preoperative swallowing screening for the elderly patients with gastrectomy for gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this single-center prospective study was to clarify the efficacy of swallowing functional screening and rehabilitation intervention for the prevention of postoperative pneumonia in patients aged 75 years or older undergoing gastrectomy for gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative pneumonia
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
swallowing functional screening
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically confirmed adenocarcinoma of the stomach
2)with cStageI-IVA gastric cancer
3)planning radical gastrectomy with lymph node dissection such as distal, total and proximal gastrectomy
4)no prior chemotherapy or radiotherapy for any malignancy
5)an Eastern Cooperative Oncology Group per formance status of 0-2
6)aged 75 years or older
7)expected sufficient oral intake perioperatively
8)adequate organ function
9)written informed consent
Key exclusion criteria
1)with infected conditions
2)with mental diseases
3)taking systemic steroid therapy
4)taking insulin therapy
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | Shigehiko |
| Middle name | |
| Last name | Yagi |
Organization
Ehime Prefectural Central Hospital
Division name
Division of Digestive Surgery
Zip code
790-0024
Address
83 Kasuga-cho, Matsuyama, Ehime
TEL
089-947-1111
goat624yagi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Obatake |
Organization
Ehime Prefectural Central Hospital
Division name
Division of Digestive Surgery
Zip code
790-0024
Address
83 Kasuga-cho, Matsuyama, Ehime
TEL
089-947-1111
Homepage URL
vwgolf3.4.audis5@gmail.com
Sponsor or person
Institute
Ehime Prefectural Central Hospital
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
Ehime Prefecural Cental Hospital
Address
83 Kasuga-cho, Matsuyama, Ehime
Tel
089-947-1111
c-volunteer@eph.pref.ehime.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
| 2021 | Year | 04 | Month | 19 | 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
| 2021 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
