UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of hyperbaric oxygen therapy in adhesive small bowel obstruction : A prospective randomized clinical trial
Title of the study (Brief title)	Impact of hyperbaric oxygen therapy in adhesive small bowel obstruction
Region	Japan

Condition
Condition	postoperative adhesive small bowel obstruction
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess the clinical value of hyperbaric oxygen therapy in adhesive small bowel obstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	successful rate of hyperbaric oxygen therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	hyperbaric oxygen therapy were treated once a day at a pressure of 2.0 atmospheres absolute, and received 100% oxygen. Sessions lasted 90 min, starting with 15 min of compression and ending with 15 min of decompression.
Interventions/Control_2	control
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)on addmission (2)placed nasogastric tube (3)hyperbaric oxygen therapy can performed within 24 hours (4)Written informed consent
Key exclusion criteria	(1)suspicion of strangulation or peritonitis (2)cancer recurrence (3)pneumothorax (4)emphysema and sinusitis (5)pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuyuki Fukami
Organization	Toyota Kosei Hospital
Division name	Surgery
Address	500-1 Josui-cho, Toyota, Aichi 470-0396, Japan
TEL	0565-43-5000
Email	yasuyuki490225@yahoo.co.jp

Public contact
Name of contact person	Yasuyuki Fukami
Organization	Toyota Kosei Hospital
Division name	Surgery
Address	500-1 Josui-cho,Toyota, Aichi 470-0396, Japan
TEL	0565-43-5000
Homepage URL
Email	yasuyuki490225@yahoo.co.jp

Sponsor
Institute	Toyota Kosei Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2013 Year 04 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 25 Day
Anticipated trial start date	2013 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 02 Day
Last modified on	2017 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012164