UMIN-CTR Clinical Trial

Basic information
Public title	The preventative effect of oral health care on postoperative pneumonia among patients who undergo esophagectomy: a multicenter retrospective study
Acronym	Oral health care on postoperative pneumonia among patients who undergo esophagectomy
Scientific Title	The preventative effect of oral health care on postoperative pneumonia among patients who undergo esophagectomy: a multicenter retrospective study
Scientific Title:Acronym	Oral health care on postoperative pneumonia among patients who undergo esophagectomy
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery Oral surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the preventative effect of oral health care on postoperative pneumonia among patients with esophageal cancer who underwent esophagectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrence of postoperative pneumonia
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	These patients were retrospectively divided into patients who received preoperative oral care from dentists and dental hygienists (oral care group) and patients who did not receive preoperative oral care (control group).
Key exclusion criteria	excluded patients who underwent endoscopic mucosal resection or endoscopic submucosal dissection
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name UMEDA
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7698
Email	mumeda@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name UMEDA
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Clinical Oral Oncology
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7698
Homepage URL
Email	mumeda@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University Graduate School of Biomedical Sciences
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	Nagasaki University
Address	Sakamoto 1-7-1 Nagasaki
Tel	+81958197698
Email	syana@nagasaki-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	2015 Year 09 Month 05 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	300
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	2015 Year 06 Month 02 Day
Date of IRB	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 06 Month 02 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The objective variable was the occurrence of postoperative pneumonia. Pneumonia was diagnosed via the presence of fever, elevated white blood cell counts, and pulmonary infiltrates requiring antibiotic therapy. we defined the predictor variables as: 1) patient factors: age, sex, body mass index, smoking habit, drinking habit, diabetes, hypertension, preoperative serum creatinine, preoperative serum albumin, and forced expiratory volume 1%; 2) tumor factors: site and stage; 3) treatment factors: thoracotomy, operation time, blood loss, neoadjuvant chemotherapy, and postoperative dysphagia; and 4) oral care intervention. Patients who had not smoked for >1 year were classified as not having a smoking habit. The tumor sites were divided into the upper, middle, and lower esophagus. Tumor staging was classified according to the Japan Esophageal Society's criteria. Postoperative dysphagia was defined as choking when the patient started a paste diet after surgery, exhibited aspiration during swallowing (via videofluoroscopic examination), or continued tube feeding at the time of discharge.

Management information
Registered date	2015 Year 09 Month 05 Day
Last modified on	2021 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021885