UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057032 |
|---|---|
| Receipt number | R000065182 |
| Scientific Title | Analysis of postoperative gastric tube drainage and radiograph with congenital jejunoileal atresia |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/02/14 15:37:43 |
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Basic information
Public title
Analysis of postoperative gastric tube drainage and radiograph with congenital jejunoileal atresia
Acronym
Analysis of postoperative gastric tube drainage and radiograph with congenital jejunoileal atresia
Scientific Title
Analysis of postoperative gastric tube drainage and radiograph with congenital jejunoileal atresia
Scientific Title:Acronym
Analysis of postoperative gastric tube drainage and radiograph with congenital jejunoileal atresia
Region
| Japan |
Condition
Condition
Congenital jejunoileal atresia
Classification by specialty
| Gastrointestinal surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Few studies have been reported on postoperative gastric tube drainage and radiographic findings in congenital jejunoileal atresia. The aim of this study is to elucidate the general course of postoperative gastric tube drainage volume, characteristics, and radiographic findings especially about bowel gas.
Basic objectives2
Others
Basic objectives -Others
If the general course of postoperative gastric tube drainage and radiographic findings in congenital jejunoileal atresia is demonstrated, indication can be obtained to avoid unnecessary medical interventions even when an increasing gastric tube drainage, biliary drainage, or changing in radiographic findings are observed in temporary.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishment of intestinal nutrition in congenital jejunoileal atresia.
Key secondary outcomes
Removal of postoperative gastric tube in congenital jejunoileal atresia.
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
| 1 | days-old | <= |
Age-upper limit
| 1 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient who underwent exploratory laparotomy for suspected jejunoileal atresia and at Shimane University Hospital.
2) Patient who was diagnosed with congenital jejunoileal atresia based on surgical findings and also was performed bowel resection and end-to-end anastomosis or membrane-resection.
3) Patient who had a postoperative gastric tube placed and also had a daily records of drainage volume and characteristics, or radiograph.
Key exclusion criteria
1) Patient with any congenital gastrointestinal disease other than congenital jejunoileal atresia.
2) Patient who underwent reoperation for congenital jejunoileal atresia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Manako |
Organization
Shimane University
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyachou, Isumo, Shimane
TEL
0853202232
junkom32@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Manako |
Organization
Shimane University
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
89-1 Enyachou, Isumo, Shimane
TEL
0853202232
Homepage URL
junkom32@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
No research funding required
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
Department of Digestive and General Surgery, Shimane University
Address
89-1 Enyachou, Isumo, Shimane
Tel
0853202232
junkom32@med.shimane-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
| 2025 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single center retrospective study about the patients who underwent operation for congenital jejunoileal atresia at Shimane University in 2012 January to 2024 December. Patient birth weight, operative findings, daily volume and characteristics of postoperative gastric tube drainage, or radiographic findings in each day, postoperative day of intestinal nutrition started or reached to full-feedings, are extracted from medical records. By summarize postoperative gastric tube drainage or radiographic findings, elucidate the general postoperative course of congenital jejunoileal atresia.
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065182
