UMIN-CTR Clinical Trial

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
Email	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
Email	nobuhara-76@umin.ac.jp

Sponsor
Institute	Hiroshima Prefectural Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048020