Clinical trial NCT05604456: Secondary Ear Reconstructions Based on Nagata Method
Official title: Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Ear Reconstructions Based on Nagata Method
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Microtia patients seeking for secondary ear reconstructions who had previously received reconstructive surgeries while the aesthetic outcomes were displeasing

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Preoperative and postoperative scores evaluated based on CNN
timeFrame: change from baseline in appearance scores at 7 months after secondary surgery
Secondary outcomes:
measure: Five-point Likert scale scores
timeFrame: at least 7 months after secondary surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Meishui Wang, Master
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.