UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046877 |
|---|---|
| Receipt number | R000053484 |
| Scientific Title | Preventive Effect of Perioperative Oral Care on Postoperative Complications of Gastrointestinal Cancer |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2022/02/10 00:26:47 |
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Basic information
Public title
Preventive Effect of Perioperative Oral Care on Postoperative Complications of Gastrointestinal Cancer
Acronym
Preventive Effect of Perioperative Oral Care on Postoperative Complications of Gastrointestinal Cancer
Scientific Title
Preventive Effect of Perioperative Oral Care on Postoperative Complications of Gastrointestinal Cancer
Scientific Title:Acronym
Preventive Effect of Perioperative Oral Care on Postoperative Complications of Gastrointestinal Cancer
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of perioperative oral care on infectious and non-infectious complications after surgery for gastrointestinal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative ileus
Key secondary outcomes
Incidence of surgical site infection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer resections at Hiroshima Prefectural Hospital (2013-2019)
Key exclusion criteria
emergency surgery
palliative surgery
transanal endoscopic microsurgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nobuhara |
Organization
Hiroshima Prefectural Hospital
Division name
Department of Dentistry and Maxillofacial Surgery
Zip code
734-8530
Address
1-5-54, Ujina-Kanda, Minami-Ku, Hiroshima
TEL
082-254-1818
nobuhara-76@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nobuhara |
Organization
Hiroshima Prefectural Hospital
Division name
Department of Dentistry and Maxillofacial Surgery
Zip code
734-8530
Address
1-5-54, Ujina-Kanda, Minami-Ku, Hiroshima
TEL
082-254-1818
Homepage URL
nobuhara-76@umin.ac.jp
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Prefectural Hospital
Address
1-5-54, Ujina-Kanda, Minami-Ku, Hiroshima
Tel
082-254-1818
yaku8989@kud.biglobe.ne.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
| 2022 | Year | 02 | Month | 17 | 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
942
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study on the preventive effect of perioperative oral care on complications such as postoperative ileus and surgical site infection in colorectal cancer
Management information
Registered date
| 2022 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053484
