UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on prevention of surgical site infection by supplemental periopreative oxygen in digestive surgery
Acronym	Supplemental perioperative oxygen and surgical site infection
Scientific Title	Prospective study on prevention of surgical site infection by supplemental periopreative oxygen in digestive surgery
Scientific Title:Acronym	Supplemental perioperative oxygen and surgical site infection
Region	Japan

Condition
Condition	Gastrointestinal surgery case over 20 years of age under general anesthesia
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of supplemental perioperative oxygen in digestive surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Occurrence of surgical site infection that occurred within 30 days after surgery
Key secondary outcomes	Complications associated with anesthesia and surgery occurred within 30 days after surgery

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	After induction of general anesthesia, the oxygen concentration is set to 80%. After extubation, 5 L of oxygen is administered up to 4 hours after surgery
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Gastrointestinal surgery case performed under general anesthesia over 20 years old The function of major organs is maintained
Key exclusion criteria	Day surgery Sever COPD Patients attending physician is determined to be inappropriate Cases consent can not be obtained
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Hasegawa
Organization	Osaka Rosai Hospital
Division name	Department of Surgery
Zip code	591-8025
Address	1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
TEL	072-252-3561
Email	j-hasegawa@osakah.johas.go.jp

Public contact
Name of contact person	1st name Chikato Middle name Last name Koga
Organization	Osaka Rosai Hospital
Division name	Department of Surgery
Zip code	591-8025
Address	1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
TEL	072-252-3561
Homepage URL
Email	ckoga@osakah.johas.go.jp

Sponsor
Institute	Osaka Rosai Hospital Department of Surgery
Institute
Department

Funding Source
Organization	Osaka Rosai Hospital Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Rosai Hospital
Address	1179-3 Nakasonecho Kita-ku Sakai-shi Osaka
Tel	072-252-3561
Email	soumukatyou@osakah.johas.go.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	大阪労災病院（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 15 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	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 30 Day
Date of IRB	2017 Year 12 Month 12 Day
Anticipated trial start date	2018 Year 01 Month 04 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 07 Month 30 Day
Date trial data considered complete	2021 Year 07 Month 31 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 15 Day
Last modified on	2021 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042608