UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060724 |
|---|---|
| Receipt number | R000069473 |
| Scientific Title | Re-exploration Rates After Free Flap Reconstruction: Comparison Between Postoperative ICU and Ward Management in a Single-Center Retrospective Cohort |
| Date of disclosure of the study information | 2026/02/21 |
| Last modified on | 2026/02/21 12:07:01 |
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Basic information
Public title
Comparison of Postoperative ICU and Ward Management After Free Flap Reconstruction: A Single-Center Retrospective Study of Re-exploration Rates
Acronym
Free Flap Reconstruction
Scientific Title
Re-exploration Rates After Free Flap Reconstruction: Comparison Between Postoperative ICU and Ward Management in a Single-Center Retrospective Cohort
Scientific Title:Acronym
FFR-ICU Cohort Study
Region
| Japan |
Condition
Condition
Head and neck diseases
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether postoperative management setting (intensive care unit versus ward) is associated with re-exploration within 30 days after free flap reconstruction in a single-center retrospective cohort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence and incidence of re-exploration within 30 days after surgery
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
1. Patients who underwent free flap reconstruction for oral and maxillofacial defects at our institution during the study period
2. Patients aged 18 years or older at the time of anesthesia consent
3. Surgery performed under general anesthesia
4. Availability of postoperative follow-up data for at least 30 days in the medical records
Key exclusion criteria
1. Cases in which the postoperative management setting (ICU or ward) could not be identified
2. Cases with missing data required to assess the primary outcome (re-exploration within 30 days)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Maeda |
Organization
Institute of Science Tokyo
Division name
Department of Dental Anesthesiology, Graduate School of Medical and Dental Science
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
81-3-5803-5548
maedas.daop@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kawauchi |
Organization
Institute of Science Tokyo
Division name
Department of Dental Anesthesiology, Graduate School of Medical and Dental Science
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
81358035548
Homepage URL
kawauchi.aki@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
Tel
+81-3-5803-5548
maedas.daop@tmd.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 | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective cohort study that examines the association between the postoperative management setting (ICU management and ward management) after free flap reconstruction and the incidence of re-exploration within 30 days after surgery.
Management information
Registered date
| 2026 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069473
