UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049631 |
|---|---|
| Receipt number | R000056519 |
| Scientific Title | Investigation of predictive factors for surgical treatment in adhesive intestinal obstruction |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2023/11/29 11:05:53 |
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Basic information
Public title
Investigation of predictive factors for surgical treatment in adhesive intestinal obstruction
Acronym
Examination of adhesive intestinal obstruction
Scientific Title
Investigation of predictive factors for surgical treatment in adhesive intestinal obstruction
Scientific Title:Acronym
Examination of adhesive intestinal obstruction
Region
| Japan |
Condition
Condition
adhesive intestinal obstruction
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with adhesive intestinal obstruction who have had a nasal ileus tube inserted, a unified method of gastrointestinal imaging using gastrografin may be used to predict surgical or conservative treatment. will be analyzed along with other clinical factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Length of hospital stay, intestinal resection rate, postoperative complications
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with adhesive intestinal obstruction who visited an emergency or outpatient clinic and were judged to require nasal ileus tube insertion, and consent was obtained.
Key exclusion criteria
strangulating bowel obstruction,
Patients with unresolved abdominal/pelvic malignancies,
Intestinal obstruction due to malignant disease, history of abdominal surgery within the past 6 weeks, <18 years old
, pregnant women, iodine allergy, history of asthma
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Sasaki |
Organization
St. Marianna University Toyoko Hospital
Division name
Digestive Disease Center
Zip code
2110063
Address
3-435 Kosugi-cho, Nakahara-ku, Kawasaki, Japan
TEL
0447222121
sasa09302005@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Sasaki |
Organization
St. Marianna University Toyoko Hospital
Division name
Digestive Disease Center
Zip code
2110063
Address
3-435 Kosugi-cho, Nakahara-ku, Kawasaki, Japan
TEL
0447222121
Homepage URL
sasa09302005@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University Toyoko Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University Toyoko Hospital
Address
3-435 Kosugi-cho, Nakahara-ku, Kawasaki, Japan
Tel
0447222121
sasa09302005@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On the 3rd day after the nasal ileus tube was inserted, a gastrographin imaging test (60 ml) was performed. The nasal ileus tube was clamped for 1 hour and then released. Perform a plain abdominal X-ray or a plain abdominal CT 3-5 hours after imaging to confirm the flow of the contrast medium. Subsequent treatment will be provided at the discretion of the attending physician.
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056519
