UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022669 |
|---|---|
| Receipt number | 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 | 2022/12/13 10:04:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
taka1.katano@gmail.com
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
https://link.springer.com/article/10.1007/s00535-020-01708-5
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00535-020-01708-5
Number of participants that the trial has enrolled
224
Results
The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91, non-inferiority P = 0.00002923).
Results date posted
| 2022 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 15 | Day |
Baseline Characteristics
All patients were initially diagnosed as adhesive small bowel obstruction based on CT findings. Baseline characteristics were well balanced and no significant differences were apparent between the two groups in terms of age, sex, history of abdominal surgery, blood data, or physical data. Abdominal CT at study enrollment revealed ascites in 44.1% of the LT group and in 50.9% of the NGT-G group, while ascites beyond the pouch of Douglas was observed in 15.3% and 19.6% of the LT and
NGT-G groups, respectively.
Participant flow
In total, 224 patients with NSASBO were enrolled to the current trial between July 2016 and November 2018, and 223 patients (after 1 patient withdrew consent) were finally
analyzed as the ITT population (LT group, n = 111; NGT-G group, n = 112)
Adverse events
No significant differences were found, but adverse events greater than Grade 4 tended to be higher in the LT group (4.5%) than in the NGT-G group (0.9%) (P=0.119).
Outcome measures
The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91, non-inferiority P = 0.00002923).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.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 |
