Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach

NCT ID: NCT06801444

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-12-11

Brief Summary

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Transoral endoscopic thyroidectomy vestibular approach (TOETVA) has the advantage of scarless cosmesis but has limitations of recurrent laryngeal nerve (RLN) palsy. Intermittent intraoperative neuromonitoring (I-IONM) techniques have been utilized during TOETVA to identify and map RLN to prevent RLN injury. However, the insult may still occur between two neural stimulations. Continuous intraoperative neuromonitoring (C-IONM) has been used in TOETVA to persistent stimulation of RLN. but only in our hospital. This rare use may be related to technical challenges. Recently, we successfully developed a novel technique of percutaneous C-IONM using an external fixator to secure the stimulation probe to steadily monitor the real-time functional status of RLN during the TOETVA. In this retrospective study, 304 patients undergone TOETVA were enrolled and divided according to the usage of IONM techniques into percutaneous or peroral intermittent and continuous groups. Patient's age, sex, BMI, thyroid disease, operation time, EMG signal and RLN palsy rate were compared to verified the feasibility, safety, and effectiveness of different IONM techniques. We hypothesized percutaneous C-IONM has the superiority in early detection of RLN injury and reducing of RLN palsy in TOETVA.

Detailed Description

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Conditions

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Thyroidectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Benign solitary or multiple thyroid nodules, follicular lesions (the largest diameter \<6.0 cm), and early papillary thyroid carcinoma (\<1 cm in diameter, without cervical lymphadenopathy)

Exclusion Criteria: History of thyroid surgery, neck radiotherapy, and recurrent laryngeal nerve paralysis; intraoperative conversion to conventional thyroidectomy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yih-Huei Uen

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yih-Huei Uen, MD

Role: CONTACT

886-4-37061668

Facility Contacts

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Yih-Huei Uen

Role: primary

886-4-37061668

References

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Chen HK, Chen CL, Wen KS, Lin YF, Lin KY, Uen YH. Application of transoral continuous intraoperative neuromonitoring in natural orifice transluminal endoscopic surgery for thyroid disease: a preliminary study. Surg Endosc. 2018 Jan;32(1):517-525. doi: 10.1007/s00464-017-5656-0. Epub 2017 Jun 22.

Reference Type BACKGROUND
PMID: 28643050 (View on PubMed)

Lamade W, Ulmer C, Seimer A, Molnar V, Meyding-Lamade U, Thon KP, Koch KP. A new system for continuous recurrent laryngeal nerve monitoring. Minim Invasive Ther Allied Technol. 2007;16(3):149-54. doi: 10.1080/13645700701383241.

Reference Type BACKGROUND
PMID: 17573619 (View on PubMed)

Schneider R, Machens A, Sekulla C, Lorenz K, Elwerr M, Dralle H. Superiority of continuous over intermittent intraoperative nerve monitoring in preventing vocal cord palsy. Br J Surg. 2021 May 27;108(5):566-573. doi: 10.1002/bjs.11901.

Reference Type BACKGROUND
PMID: 34043775 (View on PubMed)

Lombardi CP, De Waure C, Mariani M, Carnassale G, D'Amore A, Traini E, De Crea C, Raffaelli M, Damiani G. Efficacy of continuous neuromonitoring in thyroid surgery: preliminary report of a single-center experience. Gland Surg. 2019 Aug;8(4):336-342. doi: 10.21037/gs.2019.08.02.

Reference Type BACKGROUND
PMID: 31538057 (View on PubMed)

Schneider R, Randolph G, Dionigi G, Barczynski M, Chiang FY, Triponez F, Vamvakidis K, Brauckhoff K, Musholt TJ, Almquist M, Innaro N, Jimenez-Garcia A, Kraimps JL, Miyauchi A, Wojtczak B, Donatini G, Lombardi D, Muller U, Pezzullo L, Ratia T, Van Slycke S, Nguyen Thanh P, Lorenz K, Sekulla C, Machens A, Dralle H. Prospective study of vocal fold function after loss of the neuromonitoring signal in thyroid surgery: The International Neural Monitoring Study Group's POLT study. Laryngoscope. 2016 May;126(5):1260-6. doi: 10.1002/lary.25807. Epub 2015 Dec 15.

Reference Type BACKGROUND
PMID: 26667156 (View on PubMed)

Chiang FY, Lu IC, Chang PY, Sun H, Wang P, Lu XB, Chen HC, Chen HY, Kim HY, Dionigi G, Wu CW. Stimulating dissecting instruments during neuromonitoring of RLN in thyroid surgery. Laryngoscope. 2015 Dec;125(12):2832-7. doi: 10.1002/lary.25251. Epub 2015 Mar 26.

Reference Type BACKGROUND
PMID: 25809677 (View on PubMed)

Liu XL, Wu CW, Zhao YS, Wang T, Chen P, Xin JW, Li SJ, Zhang DQ, Zhang G, Fu YT, Zhao LN, Zhou L, Dionigi G, Chiang FY, Sun H. Exclusive real-time monitoring during recurrent laryngeal nerve dissection in conventional monitored thyroidectomy. Kaohsiung J Med Sci. 2016 Mar;32(3):135-41. doi: 10.1016/j.kjms.2016.02.004. Epub 2016 Mar 30.

Reference Type BACKGROUND
PMID: 27106003 (View on PubMed)

Tae K. Complications of Transoral Thyroidectomy: Overview and Update. Clin Exp Otorhinolaryngol. 2021 May;14(2):169-178. doi: 10.21053/ceo.2020.02110. Epub 2020 Nov 19.

Reference Type BACKGROUND
PMID: 33211953 (View on PubMed)

Other Identifiers

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CMUH113-REC3-170

Identifier Type: -

Identifier Source: org_study_id

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