UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051919 |
|---|---|
| Receipt number | R000059236 |
| Scientific Title | A Comparison of Fibrin Glue Versus Suture for Anchoring Fat Pedicles in Transconjunctival Lower Eyelid Blepharoplasty |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2023/08/15 22:35:15 |
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Basic information
Public title
A Comparison of Fibrin Glue Versus Suture for Anchoring Fat Pedicles in Transconjunctival Lower Eyelid Blepharoplasty
Acronym
A Comparison of Fibrin Glue Versus Suture for Anchoring Fat Pedicles in Transconjunctival Lower Eyelid Blepharoplasty
Scientific Title
A Comparison of Fibrin Glue Versus Suture for Anchoring Fat Pedicles in Transconjunctival Lower Eyelid Blepharoplasty
Scientific Title:Acronym
A Comparison of Fibrin Glue Versus Suture for Anchoring Fat Pedicles in Transconjunctival Lower Eyelid Blepharoplasty
Region
| Japan |
Condition
Condition
fat herniation of the lower eyelid
Classification by specialty
| Ophthalmology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lower eyelid blepharoplasty involves a variety of surgical techniques. In conventional procedures, fat pedicles are temporarily sutured with external skin or internally fixed with periosteum to anchor the fat. In this research, we compare a new method of anchoring fat with fibrin glue, which requires no sutures, to the conventional way of temporarily suturing with external skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We focused on three dimensions of postoperative complications, namely changes in skin color, eyelid contusion (measured by the range of contusion area), and skin tension evaluated by comparing marginal reflex distance 2 (MRD-2) before and after the operation. The severity of the complications was assessed on a scale of 0 to 3 multiple times following surgery, including at one week, two weeks, one month, two months, and three months after the operation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
a new method of anchoring fat with fibrin glue which requires no sutures
Interventions/Control_2
the conventional method of temporarily suturing with external skin
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
| 28 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent lower eyelid blepharoplasty at our clinic
Key exclusion criteria
Patients who had undergone other eyelid or orbital surgery were excluded.
Target sample size
127
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kikuchi |
Organization
Oculo Facial Clinic Tokyo
Division name
Oculo Facial Clinic Tokyo
Zip code
1040061
Address
Oculo Facial Clinic Tokyo, Ginza-Itchome Building 8F, 1-15-4 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9995
kikuchi_ryo@oculofacial.clinic
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kikuchi |
Organization
Oculo Facial Clinic Tokyo
Division name
Oculo Facial Clinic Tokyo
Zip code
1040061
Address
Oculo Facial Clinic Tokyo, Ginza-Itchome Building 8F, 1-15-4 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9995
Homepage URL
kikuchi_ryo@oculofacial.clinic
Sponsor or person
Institute
Oculo Facial Clinic Tokyo
Institute
Department
Personal name
Funding Source
Organization
Oculo Facial Clinic Tokyo
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
Shinmaebashi Kashima Oculoplastic Clinic
Address
Forest mall shimmaebashi, 180-1 Furuichi-machi, Maebashi-shi, Gumma, Japan
Tel
027-288-0224
kikuchi_ryo@oculofacial.clinic
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
| 2023 | Year | 08 | Month | 16 | 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
127
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059236
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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