UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010399 |
|---|---|
| Receipt number | R000012164 |
| Scientific Title | Impact of hyperbaric oxygen therapy in adhesive small bowel obstruction : A prospective randomized clinical trial |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2017/10/06 12:51:04 |
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Basic information
Public title
Impact of hyperbaric oxygen therapy
in adhesive small bowel obstruction
: A prospective randomized clinical trial
Acronym
Impact of hyperbaric oxygen therapy
in adhesive small bowel obstruction
Scientific Title
Impact of hyperbaric oxygen therapy
in adhesive small bowel obstruction
: A prospective randomized clinical trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fukami |
Organization
Toyota Kosei Hospital
Division name
Surgery
Zip code
Address
500-1 Josui-cho, Toyota, Aichi 470-0396, Japan
TEL
0565-43-5000
yasuyuki490225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fukami |
Organization
Toyota Kosei Hospital
Division name
Surgery
Zip code
Address
500-1 Josui-cho,Toyota, Aichi 470-0396, Japan
TEL
0565-43-5000
Homepage URL
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Toyota Kosei Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012164
