UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042082 |
|---|---|
| Receipt number | R000048020 |
| Scientific Title | Evaluation of perioperative oral care on the prevention of surgical site infection after pancreatic cancer surgery |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2022/02/09 17:45:02 |
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Basic information
Public title
Preventing Infection after Pancreatic Cancer Surgery through Oral Care
Acronym
Oral Care and Pancreatic Cancer
Scientific Title
Evaluation of perioperative oral care on the prevention of surgical site infection after pancreatic cancer surgery
Scientific Title:Acronym
Oral Care and SSI after Pancreatic Cancer Surgery
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of oral care in preventing surgical site infection after pancreatic cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of surgical site infections after pancreatic cancer surgery in the oral care intervention group and non-intervention group
Key secondary outcomes
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
Pancreatic cancer surgery cases in Hiroshima Prefectural Hospital (2011-2018)
Key exclusion criteria
Severe organ dysfunction
Severe psychiatric disease
Severe neuromuscular disease
Simultaneous resection of other gastroenterological cancer
Emergency operation
Target sample size
100
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
| 2020 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Supportive Care in Cancer https://doi.org/10.1007/s00520-021-06791-9
Publication of results
Published
Result
URL related to results and publications
Supportive Care in Cancer https://doi.org/10.1007/s00520-021-06791-9
Number of participants that the trial has enrolled
103
Results
The incidence of SSIs was significantly lower in the oral care group than in the control group (12.0% vs. 39.3%, P = 0.004). Logistic regression analysis revealed that a soft pancreas, the surgical procedure (pancreaticoduodenectomy), blood transfusion, diabetes mellitus, and the absence of oral care intervention were risk factors for SSIs. The odds ratio for the absence of oral care intervention was 6.090 (95% confidence interval: 1.750-21.200, P = 0.004).
Results date posted
| 2022 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 103 patients with PDAC who underwent radical resection at Hiroshima Prefectural Hospital (2011-2018) were enrolled in this study.
Participant flow
Of the 103 patients, 75 received perioperative oral care by dentists and dental hygienists (oral care group), whereas 28 did not (control group).
Adverse events
none
Outcome measures
SSI(Incisional SSI, Organ/space SSI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study of the incidence of postoperative surgical site infection, along with various patient, disease-related, and treatment factors, in pancreatic cancer intervention and non-intervention groups for perioperative oral care.
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048020
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