UMIN-CTR Clinical Trial

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

Esophageal cancer

Classification by specialty

Gastrointestinal surgery	Oral surgery	Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

occurrence of postoperative pneumonia

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Nagasaki University Graduate School of Biomedical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagasaki University

Address

Sakamoto 1-7-1 Nagasaki

Tel

+81958197698

Email

syana@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

09

Month

05

Day

Last modified on

2021

Year

09

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021885