UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060508 |
|---|---|
| Receipt number | R000069192 |
| Scientific Title | Optimal Tentative Abdominal Closure for Lower Gastrointestinal Perforation |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/29 10:21:11 |
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Basic information
Public title
Optimal Tentative Abdominal Closure for Lower Gastrointestinal Perforation
Acronym
OPTITAC II trial
Scientific Title
Optimal Tentative Abdominal Closure for Lower Gastrointestinal Perforation
Scientific Title:Acronym
OPTITAC II trial
Region
| Japan |
Condition
Condition
Patients who underwent open abdomen for lower gastrointestinal perforation
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the optimal methods of tentative abdominal closure for lower gastrointestinal perforation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary fascial closure
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 with lower gastrointestinal perforation who underwent open abdomen between April 2016 and March 2026
Key exclusion criteria
Patients who died within 48 h after the initial surgery of open abdomen
Patients who had DNAR order within 48 h after the initial surgery of open abdomen
Patients with ventral hernia that was diagnosed before open abdomen and fascia could not be closed due to the hernia
Patients with appendiceal perforation as the sole diagnosis
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3225-1323
ryoyamamoto@keio.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Kujirai |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
manu@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Abdominal Emergency Medicine
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
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients with lower gastrointestinal perforation who underwent open abdomen management in Japan, we examined patient characteristics, disease severity, operative variables, and intensive care management associated with the rate of primary fascial closure. Descriptive statistics, univariable analyses, and multivariable analyses are performed, including generalized estimating equations, logistic regression analysis, and propensity score-based analyses.
In the multivariable analyses, clinically relevant confounders selected based on prior studies and clinical plausibility (such as age, sex, comorbidities, and preoperative condition) were included in the models as adjustment variables.
In addition, subgroup analyses stratified by disease etiology and severity are conducted in this study.
Management information
Registered date
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069192
