UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056584 |
|---|---|
| Receipt number | R000064662 |
| Scientific Title | Early Postoperative Complications in Microvascular Mandibular Reconstruction: A Comparative Analysis Using Comprehensive Complication Index |
| Date of disclosure of the study information | 2024/12/26 |
| Last modified on | 2024/12/26 19:50:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Early Postoperative Complications in Microvascular Mandibular Reconstruction: A Comparative Analysis Using Comprehensive Complication Index
Acronym
Early Postoperative Complications in Microvascular Mandibular Reconstruction: A Comparative Analysis Using Comprehensive Complication Index
Scientific Title
Early Postoperative Complications in Microvascular Mandibular Reconstruction: A Comparative Analysis Using Comprehensive Complication Index
Scientific Title:Acronym
Early Postoperative Complications in Microvascular Mandibular Reconstruction: A Comparative Analysis Using Comprehensive Complication Index
Region
| Japan |
Condition
Condition
patients who underwent microvascular mandibular reconstruction immediately after head and neck tumor ablative surgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare early complication risks among the three mandibular reconstruction methods (vascularized bone grafts, mandibular reconstruction plates, and soft tissue flaps) using the Comprehensive Complication Index
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive Complication Index
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
| 1 | years-old | <= |
Age-upper limit
| 200 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This retrospective observational study included all patients who underwent microvascular mandibular reconstruction immediately after head and neck tumor ablative surgery at our institution between January 1, 2017, and December 31, 2023.
Key exclusion criteria
Secondary reconstructions and reoperations were excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
09061377950
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
2778577
Address
6-5-1 Kashiwanoha
TEL
09061377950
Homepage URL
tahidaka1986@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha
Tel
09061377950
tahidaka1986@gmail.com
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
| 2024 | Year | 12 | Month | 26 | 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
101
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | 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
The Comprehensive Complication Index (CCI), calculated based on the Clavien-Dindo classification, was used as the primary outcome to evaluate early postoperative complications occurring within 30 days. Patient characteristics and the CCI were compared across the vascularized bone graft, mandibular reconstruction plate, and soft tissue flap groups using statistical analyses including multivariable linear regression.
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064662
