UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044619 |
|---|---|
| Receipt number | R000050757 |
| Scientific Title | Optimal Tentative Abdominal Closure for Open Abdomen |
| Date of disclosure of the study information | 2021/06/23 |
| Last modified on | 2023/08/08 23:19:40 |
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Basic information
Public title
Optimal Tentative Abdominal Closure for Open Abdomen
Acronym
OPTITAC trial
Scientific Title
Optimal Tentative Abdominal Closure for Open Abdomen
Scientific Title:Acronym
OPTITAC trial
Region
| Japan |
Condition
Condition
Patients who underwent open abdomen
Classification by specialty
| Surgery in general | 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 open abdomen
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary fascia closure
Key secondary outcomes
Days to primary fascia closure, adverse events (enteroatmospheric fistula, anastomotic leakage, wound dehiscence, ventral hernia, surgical site infection, any other fistula), 28day mortality, in-hospital mortality, ICU free days to day28, ventilator free days to day28, RRT free days to day28, hospital free days to day28, SOFA and APACHEII score at day7 after initiating open abdomen, re-admission within 30 days after discharge, disposition at discharge
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 who underwent open abdomen between January 2010 and March 2021
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
Target sample size
250
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 | 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
Homepage URL
ryoyamamoto@keio.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, 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
Keio University School of Medicine, Tokyo, Japan
Keio University Hospital, Tokyo, Japan
Saiseikai Utsunomiya Hospital, Tochigi, Japan
Saiseikai Central Hospital, Tokyo, Japan
National Hospital Organization Tokyo Medical Center, Tokyo, Japan
Saiseikai Yokohamashi Tobu Hospital, Kanagawa, Japan
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 23 | 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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
The association between methods of tentative abdominal closure for open abdomen and outcomes are planned to be analyzed as primary analyses. Details of tentative abdominal closure include use of NPWT, type of NPWT, degree of negative pressure in NPWT, presence of continuous irrigation during NPWT, type of dynamic closure technique, and frequency of dressing change of open abdomen.
Adjusted analyses are also planned, using multivariate regression analyses and/or propensity score analyses, depending on the number of included cases and frequency of outcomes. Covariates include patient demographics (age, gender, height, weight, comorbidities, medications, and thickness of abdominal wall), therapeutic variables (diagnosis, vital signs before and during surgery, preoperative SOFA score, type of surgery, indication for open abdomen, and fluid administration and transfusion before, during, and after surgery), duration of antibiotics, postoperative lactate, blood test before and after surgery until day 7, and institution variables, such as number of patients with open abdomen, number of surgeons, and number of beds.
Moreover, to further understand the relationship between the details of tentative abdominal closure and outcomes, several secondary analyses are planned, in which effects of differences in diagnosis, thickness of abdominal wall, fluid balance before and during surgery, and postoperative lactate on outcomes are examined.
Management information
Registered date
| 2021 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050757
