UMIN-CTR Clinical Trial

Basic information
Public title	Effects of periodontal disease and oral bacteria on postoperative complications of gastric cancer surgery
Acronym	Effects of periodontal disease and oral bacteria on postoperative complications of gastric cancer surgery
Scientific Title	Effects of periodontal disease and oral bacteria on postoperative complications of gastric cancer surgery
Scientific Title:Acronym	Effects of periodontal disease and oral bacteria on postoperative complications of gastric cancer surgery
Region	Japan

Condition
Condition	Patient after gastric cancer surgery
Classification by specialty	Gastrointestinal surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intraoral environment and oral bacteria in the patient are fact-finding of periodontal disease about the participation for the outbreak of complications after art in stomach cancer preoperation.
Basic objectives2	Others
Basic objectives -Others	Investigation of direct involvement of oral bacteria in patients with periodontal disease on the occurrence of postoperative infectious complications.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	nvestigate the risk of infectious complications for severity of circumference disease, PPD, the number of remaining teeth, the type and amount of bacteria in the periodontal pocket and gastric mucosa.
Key secondary outcomes	Comparison of types and amounts of bacteria in the periodontal pocket and the gastric mucosal surface.

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	1) Patients diagnosed as histologically adenocarcinoma of the stomach and scheduled curative surgery at our hospital. 2) Patients with evaluation of oral environment before surgery
Key exclusion criteria	1) Patients in which the occurrence of postoperative complications is unknown (eg, earlier transplant cases). 2) Patients of emergency surgery. 3)Patients in which gastrectomy could not be performed due to intraoperative findings.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mao Nishikawa
Organization	Southern Tohokou General Hospital
Division name	Oral and Maxillofacial Surgery
Zip code
Address	Hachiyamada 7-115, Kouriyama City, Fukushima
TEL	024-934-5322
Email	mao.nishikawa@mt.strins.or.jp

Public contact
Name of contact person	1st name Middle name Last name Mao Nishikawa
Organization	Southern Tohokou General Hospital
Division name	Oral and Maxillofacial Surgery
Zip code
Address	Hachiyamada 7-115, Kouriyama City, Fukushima
TEL	024-934-5322
Homepage URL
Email	mao.nishikawa@mt.strins.or.jp

Sponsor
Institute	Southern Tohokou General Hospital
Institute
Department

Funding Source
Organization	Self-sourcing
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
Address
Tel
Email

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	2018 Year 08 Month 22 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	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non

Management information
Registered date	2018 Year 08 Month 21 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038430