Secondary Ear Reconstructions Based on Nagata MethodNCT05604456
Secondary Ear Reconstructions Based on Nagata Method
An observational study of Secondary Ear Reconstructions Based on Nagata Method, run by Xiaohui Su at 1 site in China.
Trial summary
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Secondary Ear Reconstructions Based on Nagata Method
- What is being tested?
- secondary ear reconstruction based on Nagata method
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Microtia patients seeking for secondary ear reconstructions who had previously received reconstructive surgeries while the aesthetic outcomes were displeasing
Who may be able to join
- Chest circumference larger than 60cm at the lowest sternum level;
- Willingness to participate long-term follow-ups;
- Ability to correctly understand the questionnaire(>8 years old).
Who cannot join
- Patients with damaged superficial temporal artery (STA);
- Patients with poor condition of rib cartilage;
- Patients with active inflammation in auricular area;
- Patients who refuses surgical approach.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
About this study
Official title: Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is:
- Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.
- Being tested
- secondary ear reconstruction based on Nagata method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secondary ear reconstruction based on Nagata methodProcedure or surgery
Secondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision.
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative and postoperative scores evaluated based on CNN
Preoperative and postoperative photographs were acquired for reconstructed ear evaluation of its realness and appearance improvement through convolutional neural network (CNN) models we previously developed.
Measured: change from baseline in appearance scores at 7 months after secondary surgery
Secondary outcomes (1)
Five-point Likert scale scores
Five-point Likert scale score will be collected to show patient-reported outcomes in the follow-up study through questionnaires to assess patients' postoperative satisfaction. This questionnaire includes overall appearance, size, projection and subunits of the ear and the postoperative status of donor site. 1 = poor and 5 = excellent.
Measured: at least 7 months after secondary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 May 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Secondary Ear Reconstructions Based on Nagata MethodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaohui Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaohui Su, First Affiliated Hospital of Fujian Medical University
- Investigators
- Meishui Wang, Master, Study chair, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604456
- Sponsor's protocol ID
- SERNM
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Long X, Yu N, Huang J, Wang X. Complication rate of autologous cartilage microtia reconstruction: a systematic review. Plast Reconstr Surg Glob Open. 2013 Nov 7;1(7):e57. doi: 10.1097/GOX.0b013e3182aa8784. eCollection 2013 Oct.
PubMed 25289252Akter F, Mennie JC, Stewart K, Bulstrode N. Patient reported outcome measures in microtia surgery. J Plast Reconstr Aesthet Surg. 2017 Mar;70(3):416-424. doi: 10.1016/j.bjps.2016.10.023. Epub 2016 Nov 23.
PubMed 28041938Ye J, Lei C, Wei Z, Wang Y, Zheng H, Wang M, Wang B. Evaluation of reconstructed auricles by convolutional neural networks. J Plast Reconstr Aesthet Surg. 2022 Jul;75(7):2293-2301. doi: 10.1016/j.bjps.2022.01.037. Epub 2022 Jan 31.
PubMed 35183463Reinisch JF, van Hovell Tot Westerflier CVA, Gould DJ, Tahiri YT. Secondary Salvage of the Unsatisfactory Microtia Reconstruction. Plast Reconstr Surg. 2020 May;145(5):1252-1261. doi: 10.1097/PRS.0000000000006766.
PubMed 32332549Yue X, Jiang H, Pan B, He L, Dong W, Yang Q. Secondary surgery for the unsatisfactory auricle after auricular reconstruction. Int J Pediatr Otorhinolaryngol. 2022 Mar;154:111043. doi: 10.1016/j.ijporl.2022.111043. Epub 2022 Jan 14.
PubMed 35063805Ronde EM, Esposito M, Lin Y, van Etten-Jamaludin FS, Bulstrode NW, Breugem CC. Long-term complications of microtia reconstruction: A systematic review. J Plast Reconstr Aesthet Surg. 2021 Dec;74(12):3235-3250. doi: 10.1016/j.bjps.2021.08.001. Epub 2021 Aug 17.
PubMed 34481742Varni JW, Limbers CA, Burwinkle TM. How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:1. doi: 10.1186/1477-7525-5-1.
PubMed 17201920Lee TS, Lim SY, Pyon JK, Mun GH, Bang SI, Oh KS. Secondary revisions due to unfavourable results after microtia reconstruction. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):940-6. doi: 10.1016/j.bjps.2009.04.016. Epub 2009 May 17.
PubMed 19451041Su XH, Ye J, Lei C, Wei SJ, Zheng HB, Shan XY, Wang B, Wang MS. Secondary ear reconstruction based on the Nagata method after unsatisfactory microtia surgery outcomes. J Plast Reconstr Aesthet Surg. 2023 Dec;87:251-258. doi: 10.1016/j.bjps.2023.10.075. Epub 2023 Oct 14.
PubMed 37924716
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries
- ClinicalTrials.gov ID
- NCT05604456
- Acronym / sponsor ID
- SERNM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Xiaohui SuUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is:
- Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Microtia patients seeking for secondary ear reconstructions who had previously received reconstructive surgeries while the aesthetic outcomes were displeasing
Key inclusion criteria (3 listed)
- Chest circumference larger than 60cm at the lowest sternum level;
- Willingness to participate long-term follow-ups;
- Ability to correctly understand the questionnaire(>8 years old).
Key exclusion criteria (4 listed)
- Patients with damaged superficial temporal artery (STA);
- Patients with poor condition of rib cartilage;
- Patients with active inflammation in auricular area;
- Patients who refuses surgical approach.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secondary ear reconstruction based on Nagata methodSecondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision. | Procedure or surgery | – |
Primary outcome
Preoperative and postoperative scores evaluated based on CNN
Time frame: change from baseline in appearance scores at 7 months after secondary surgery
Preoperative and postoperative photographs were acquired for reconstructed ear evaluation of its realness and appearance improvement through convolutional neural network (CNN) models we previously developed.
1 secondary outcome
Five-point Likert scale scores
Time frame: at least 7 months after secondary surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 25289252Long X, Yu N, Huang J, Wang X. Complication rate of autologous cartilage microtia reconstruction: a systematic review. Plast Reconstr Surg Glob Open. 2013 Nov 7;1(7):e57. doi: 10.1097/GOX.0b013e3182aa8784. eCollection 2013 Oct.
- Background: PubMed 28041938Akter F, Mennie JC, Stewart K, Bulstrode N. Patient reported outcome measures in microtia surgery. J Plast Reconstr Aesthet Surg. 2017 Mar;70(3):416-424. doi: 10.1016/j.bjps.2016.10.023. Epub 2016 Nov 23.
- Background: PubMed 35183463Ye J, Lei C, Wei Z, Wang Y, Zheng H, Wang M, Wang B. Evaluation of reconstructed auricles by convolutional neural networks. J Plast Reconstr Aesthet Surg. 2022 Jul;75(7):2293-2301. doi: 10.1016/j.bjps.2022.01.037. Epub 2022 Jan 31.
- Background: PubMed 32332549Reinisch JF, van Hovell Tot Westerflier CVA, Gould DJ, Tahiri YT. Secondary Salvage of the Unsatisfactory Microtia Reconstruction. Plast Reconstr Surg. 2020 May;145(5):1252-1261. doi: 10.1097/PRS.0000000000006766.
- Background: PubMed 35063805Yue X, Jiang H, Pan B, He L, Dong W, Yang Q. Secondary surgery for the unsatisfactory auricle after auricular reconstruction. Int J Pediatr Otorhinolaryngol. 2022 Mar;154:111043. doi: 10.1016/j.ijporl.2022.111043. Epub 2022 Jan 14.
- Background: PubMed 34481742Ronde EM, Esposito M, Lin Y, van Etten-Jamaludin FS, Bulstrode NW, Breugem CC. Long-term complications of microtia reconstruction: A systematic review. J Plast Reconstr Aesthet Surg. 2021 Dec;74(12):3235-3250. doi: 10.1016/j.bjps.2021.08.001. Epub 2021 Aug 17.
- Background: PubMed 17201920Varni JW, Limbers CA, Burwinkle TM. How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:1. doi: 10.1186/1477-7525-5-1.
- Background: PubMed 19451041Lee TS, Lim SY, Pyon JK, Mun GH, Bang SI, Oh KS. Secondary revisions due to unfavourable results after microtia reconstruction. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):940-6. doi: 10.1016/j.bjps.2009.04.016. Epub 2009 May 17.
- Derived from this study: PubMed 37924716Su XH, Ye J, Lei C, Wei SJ, Zheng HB, Shan XY, Wang B, Wang MS. Secondary ear reconstruction based on the Nagata method after unsatisfactory microtia surgery outcomes. J Plast Reconstr Aesthet Surg. 2023 Dec;87:251-258. doi: 10.1016/j.bjps.2023.10.075. Epub 2023 Oct 14.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meishui Wang, Master study chair
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Ear Reconstructions Based on Nagata Method, run by Xiaohui Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative and postoperative scores evaluated based on CNN (time frame: change from baseline in appearance scores at 7 months after secondary surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604456, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.