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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022669
Receipt No. R000025714
Scientific Title Randomized controlled trial of long tube vs. nasogastric tube with Gastrografin for adhesive small bowel obstruction
Date of disclosure of the study information 2016/07/01
Last modified on 2019/06/11

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Basic information
Public title Randomized controlled trial of long tube vs. nasogastric tube with Gastrografin for adhesive small bowel obstruction
Acronym Randomized controlled trial for adhesive small bowel obstruction
Scientific Title Randomized controlled trial of long tube vs. nasogastric tube with Gastrografin for adhesive small bowel obstruction
Scientific Title:Acronym Randomized controlled trial for adhesive small bowel obstruction
Region
Japan

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

Objectives
Narrative objectives1 To assess non-inferiority of nasogastirc tube with Gastrografin (NGT-G) to long tube for adhesive smal bowel obstruction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Non-surgery rate (Treatment success rate)
Key secondary outcomes Success rate of LT and non-cross over NCT-G, Time to improvement, Time for placement of tube, Duration of hospital stay, Adverse event, Motality, Diagnostic accuracy of NGT-G for indication of surgery

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Long tube
Interventions/Control_2 Nasogastric tube with 90ml of Gastrografin
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 1. Diagnosis of small bowel ileus with CT scan
2. Age from 20 to 90 years old
3. Agreement with signed informed consent
Key exclusion criteria 1. Diagnosis of strangulated ileus
2. Severe condition with shock vital, severe infection and severe dysfunction of lung, renal and heart
3. Impossibility of tube placement including performance status 4, dementia and dysphagia
4. Obstruction from nasal cavity to duodenum
5. Previous removal of whole stomach
6. Carcinomatous peritonitis
7. Allergic history for iodin or iodin contrust agent
8. Pregnancy
9. Inappropriateness with physician's judgement
Target sample size 220

Research contact person
Name of lead principal investigator
1st name Takaya
Middle name
Last name Shimura
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Email tshimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Takahito
Middle name
Last name Katano
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8211
Homepage URL
Email taka1.katano@gmail.com

Sponsor
Institute Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nagoya City University Hospital, Japanese Red Cross Nagoya Daini Hospital, Aichi Medical University Hospital, Gifu Prefectural Tajimi Hospital, Chukyo Hospital, Nagoya City East Medical Center, Nagoya City West Medical Center, Nagoya Memorial Hospital, Toyokawa City Hospital, Gamagori City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Management Center
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel 052-853-8211
Email tshimura@med.nagoya-cu.ac.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 名古屋市立大学病院(愛知県)、名古屋第二赤十字病院(愛知県)、愛知医科大学病院(愛知県)、岐阜県立多治見病院(岐阜県)、中京病院(愛知県)、名古屋市立東部医療センター(愛知県)、名古屋市立西部医療センター(愛知県)、名古屋記念病院(愛知県)、豊川市民病院(愛知県)、蒲郡市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
2016 Year 05 Month 26 Day
Date of IRB
2016 Year 06 Month 06 Day
Anticipated trial start date
2016 Year 07 Month 16 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 08 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025714

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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