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Recruitment status
Unique ID issued by UMIN UMIN000022612
Receipt No. R000026062
Scientific Title Comparison between Gastrografin Administratoin via Nasogastric Tube and Transnasal Decompression Tube for Adhesive Small Bowel Obstruction: Randomized controlled trial
Date of disclosure of the study information 2016/06/04
Last modified on 2016/06/04

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Basic information
Public title Comparison between Gastrografin Administratoin via Nasogastric Tube and Transnasal Decompression Tube for Adhesive Small Bowel Obstruction: Randomized controlled trial
Acronym ASBO Study
Scientific Title Comparison between Gastrografin Administratoin via Nasogastric Tube and Transnasal Decompression Tube for Adhesive Small Bowel Obstruction: Randomized controlled trial
Scientific Title:Acronym ASBO Study
Region
Japan

Condition
Condition Adhesive small bowel obstruction
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to explore the effectiveness of gastrografin administration via nasogastric tube for adhesive small bowel obstruction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Treatment success rate without surgery
Key secondary outcomes duration for recovery, length of hospital stay, complications(SSI, fistula, strangulation, pneumonia, sepsis, adverse effect), discharge volume, surgical procedure, surgery duration, blood exam, abdominal X-ray

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 gastrografin administration via nasogastric tube
Interventions/Control_2 transnasal decompression tube
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
90 years-old >
Gender Male and Female
Key inclusion criteria symptomatic adhesive small bowel obstruction
diagnosed by imaging (X-P, CT)
without any intestinal decompression
Key exclusion criteria no requirement for decompression
strangulated, carcinomatosis, peritonitis-induced
pregnancy
within 30 days after surgery
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihisa Matsuda
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Department of Surgery
Zip code
Address 1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL 0476991111
Email a-matsu@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihisa Matsuda
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Department of Surgery
Zip code
Address 1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL 0476991111
Homepage URL
Email a-matsu@nms.ac.jp

Sponsor
Institute Department of Surgery, Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization Department of Surgery, Nippon Medical School Chiba Hokusoh Hospital
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
Email

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 日本医科大学千葉北総病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 04 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
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 04 Day
Last modified on
2016 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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