UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054486 |
|---|---|
| Receipt number | R000062238 |
| Scientific Title | A Retrospective Study of Early and Late Complications of fibula flap Reconstruction after Midface Defect |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/25 16:15:54 |
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Basic information
Public title
Investigation of complications following fibula flap reconstruction after facial resection.
Acronym
Investigation of complications following fibula flap reconstruction after facial resection.
Scientific Title
A Retrospective Study of Early and Late Complications of fibula flap Reconstruction after Midface Defect
Scientific Title:Acronym
A Retrospective Study of Early and Late Complications of fibula flap Reconstruction after Midface Defect
Region
| Japan |
Condition
Condition
maxilla neoplasm
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect information on perioperative surgical outcomes (early and delayed complications) in patients with midface defects undergoing fibula flap reconstruction and to determine the safety of the procedure as the primary endpoint. A longitudinal, single-center, retrospective, case-control study of data from patients with fibula flap reconstruction after midface defects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative complications (vascular anastomotic thrombus, fibula flap necrosis, total skin flap necrosis, wound infection, hematoma, oronasal fistula, osteoradionecrosis of the jaw, delayed osteonecrosis, etc.)
Key secondary outcomes
oral rehabilitation (jaw dentures or dental implants) and oral function
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Since the Department of Plastic and Reconstructive Surgery at either the Jikei University Hospital or Kashiwa Hospital performs fibula flap reconstruction on approximately 4 to 6 patients with midface defects per year, and the case registration period is 17 years, the target number of cases was set at 70. Selection criteria were those who had undergone head and neck reconstructive surgery to reconstruct the midfacial region and were at least 18 years old.
Key exclusion criteria
Persons who refuse to participate in the research
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Ishida |
Organization
Jikei university school of medicine
Division name
Plastic and reconstructive surgery
Zip code
105-8471
Address
3-19-18 Nishishinbashi Minato-ku Tokyo Japan
TEL
0334331111
katsu@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Ishida |
Organization
Jikei university school of medicine
Division name
Plastic and reconstructive surgery
Zip code
105-8471
Address
3-19-18 Nishishinbashi Minato-ku Tokyo Japan
TEL
0334331111
Homepage URL
katsu@jikei.ac.jp
Sponsor or person
Institute
Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei university school of medicine Institutional review board
Address
3-19-18 Nishishinbashi Minato-ku Tokyo Japan
Tel
0334331111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
35-251(11880)
Org. issuing International ID_1
Jikei university school of medicine
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 | 06 | 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
70
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
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 04 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 04 | Day |
Other
Other related information
Observation and examination
Patient factors: gender, age, comorbidity, height, weight, staging, BMI, feeding function, etc.
Blood test results
Bacterial culture results: perioperative
Imaging findings: Xp, CT, bone scintigraphy, MRI, PET
Surgical record: operation time, blood loss, ASA-PS, antibiotic administration interval anesthesia chart record
Perioperative course
Local perioperative complications
Perioperative complications
Oral rehabilitation
Management information
Registered date
| 2024 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062238
