Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
7 participants
OBSERVATIONAL
2022-05-01
2022-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Connecting the Residual Ear to the Cartilage Scaffold in First- vs. Second-Stage Surgery
NCT06763991
Postoperative Follow up After Head and Face Reconstructive Surgeries
NCT04405687
Clinical Outcomes of Thoracodorsal Artery Flap in Oral and Maxillofacial Reconstruction
NCT06599801
Head and Neck Quality of Life
NCT06756763
Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma
NCT06246682
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
secondary ear reconstruction based on Nagata method
Secondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willingness to participate long-term follow-ups;
* Ability to correctly understand the questionnaire(\>8 years old).
Exclusion Criteria
* Patients with poor condition of rib cartilage;
* Patients with active inflammation in auricular area;
* Patients who refuses surgical approach.
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiaohui Su
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaohui Su
Clinical Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Meishui Wang, Master
Role: STUDY_CHAIR
First Affiliated Hospital of Fujian Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Akter 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.
Ye 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.
Reinisch 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.
Yue 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.
Ronde 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.
Varni 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.
Lee 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.
Su 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SERNM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.