UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037961 |
|---|---|
| Receipt number | R000043227 |
| Scientific Title | Assessment of the perioperative oral management after operation of digestive organ cancer |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2022/09/12 13:37:44 |
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Basic information
Public title
Assessment of the perioperative oral management after operation of digestive organ cancer
an effective intervention procedure
Acronym
Oral management for digestive organ cancer
Scientific Title
Assessment of the perioperative oral management after operation of digestive organ cancer
Scientific Title:Acronym
Oral management for digestive organ cancer
Region
| Japan |
Condition
Condition
digestive organ cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of oral management to prevent surgical site infection or complications in patients after a digestive organ cancer operation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Surgical site infection, pneumoniae after operation
Key secondary outcomes
Other uninfected complications after operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Oral management is not performed.
Interventions/Control_2
Oral management is performed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent the resection of digestive organ cancer in a Kagoshima University Hospital and collaborative facilities during from January 1st, 2014 to December 31th, 2016
Key exclusion criteria
Patients applicable with even one following houses are exclude.
1. The case that a surgical stress is slight
2. The patient whom researchers judged to be inappropriate as a study subject
3. The patient who had declaration of intention of the nonparticipation
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Taihei |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kagoshima University
Division name
Department of Preventive Dentistry
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-6182
yamatai@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Taihei |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kagoshima University
Division name
Department of Preventive Dentistry
Zip code
890-8544
Address
890
TEL
099-275-6182
Homepage URL
yamatai@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Ten facilities
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Epidemiological Studies, Kagoshima University
Address
8-35-1, Sakuragaoka, Kagoshima
Tel
099-275-6090
isgskkrs@kuas.kagoshima-u.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
| 2019 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
4164
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
A part of this project was published in international journals. A study about pancreaticoduodenectomy is preparing for publication now.
Date of the first journal publication of results
| 2020 | Year | 01 | Month | 02 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043227
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/09/12 | 3.keikakusyo_ver1.6 済.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
