Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma
17. september 2026 oppdatert av: Serkan Karaisli, Izmir Katip Celebi University
Aim: Intraoperative neuromonitoring (IONM) is frequently used in cases of primary hyperparathyroidism (pHPT); however, its role in cases of solitary parathyroid adenoma has not been clearly defined, and differing opinions exist on the matter. This study aimed to evaluate the impact of IONM on surgical outcomes in patients undergoing parathyroidectomy for solitary parathyroid adenoma.
Methods: Patients with localized solitary parathyroid adenoma were operated on by experienced endocrine surgeons at our clinic. Patients undergoing four-gland exploration or unilateral exploration, as well as those with a history of neck surgery and/or radiotherapy, were excluded from the study. Patient data were analyzed prospectively. Patients were divided into two groups: those who underwent IONM and those who did not. Demographic characteristics, preoperative and intraoperative data, and postoperative follow-up results were compared between the groups. The IONM procedure was performed in accordance with international IONM standards. Patients were randomized prior to surgery by a resident physician using a method where they drew a card from a bag.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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İzmir
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Izmir, İzmir, Tyrkia (Türkiye), 35100
- Izmir Katip Celebi University Ataturk Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Being 18 years of age or older,
- The adenoma being localized to the same location on both ultrasound and scintigraphy
- No history of neck intervention for any reason,
- No planned concurrent thyroid surgery or four-gland exploration,
- Normal preoperative vocal cord assessment.
Exclusion Criteria:
- Being under the age of 18,
- Having undergone thyroid and parathyroid surgery,
- Cases known to be familial preoperatively,
- Cases scheduled for four-gland exploration,
- Cases with a history of neck radiotherapy.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: IONM GROUP
Patients undergoing parathyroid surgery with intraoperative neuromonitoring. |
INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION. |
|
Ingen inngripen: NON-IONM GROUP
Patients undergoing parathyroid surgery without intraoperative neuromonitoring. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
Tidsramme: Postoperative Day 1 and 1 Week After Surgery
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Postoperative vocal cord function will be assessed by laryngoscopic examination and reported as the number and percentage of patients with normal or abnormal vocal cord function |
Postoperative Day 1 and 1 Week After Surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
Tidsramme: 10th minute after parathyroidectomy
|
Surgical success will be assessed according to the Miami criterion, defined as a ≥50% decrease in intraoperative parathyroid hormone (IOPTH) level from the highest pre-excision or baseline value to the 10-minute post-excision measurement. The outcome will be reported as the number and percentage of patients meeting the Miami criterion. |
10th minute after parathyroidectomy
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Operative Time, Reported in Minutes
Tidsramme: During surgery
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Operative time will be measured from the beginning of the surgical incision to completion of skin closure and will be reported in minutes. |
During surgery
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Incision Length, Reported in Millimeters
Tidsramme: At the end of surgery
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The length of the surgical incision will be measured at the end of the surgical procedure and reported in millimeters. |
At the end of surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: MEHMET HACIYANLI, MD, Izmir Katip Celebi University Ataturk Training and Research Hospital
- Hovedetterforsker: MERT YOLDAŞ, Izmir Katip Celebi University Ataturk Training and Research Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kempster GB, Gerratt BR, Verdolini Abbott K, Barkmeier-Kraemer J, Hillman RE. Consensus auditory-perceptual evaluation of voice: development of a standardized clinical protocol. Am J Speech Lang Pathol. 2009 May;18(2):124-32. doi: 10.1044/1058-0360(2008/08-0017). Epub 2008 Oct 16.
- Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.
- Noureldine SI, Gooi Z, Tufano RP. Minimally invasive parathyroid surgery. Gland Surg. 2015 Oct;4(5):410-9. doi: 10.3978/j.issn.2227-684X.2015.03.07.
- Bilezikian JP, Cusano NE, Khan AA, Liu JM, Marcocci C, Bandeira F. Primary hyperparathyroidism. Nat Rev Dis Primers. 2016 May 19;2:16033. doi: 10.1038/nrdp.2016.33.
- Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.
- andolph GW, editor. Surgery of the thyroid and parathyroid glands. 3rd ed. Philadelphia: Elsevier; 2021.
- Duran-Poveda M, Vidal Perez O, Martos Martinez JM, Gluckmann Maldonado E, Villar-Del-Moral J, de la Quintana Basarrate A, Rodriguez-Caravaca G, Grao Torrente I, Diaz Vico T. Adherence to international neural monitoring study group (INMSG) guidelines for intraoperative nerve monitoring in thyroid and parathyroid surgery. A survey of endocrine surgeons in Spain. Sci Rep. 2026 Mar 14;16(1):13499. doi: 10.1038/s41598-026-43651-0.
- Saxe A, Idris M, Gemechu J. Does the Use of Intraoperative Neuromonitoring during Thyroid and Parathyroid Surgery Reduce the Incidence of Recurrent Laryngeal Nerve Injuries? A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2024 Apr 23;14(9):860. doi: 10.3390/diagnostics14090860.
- Conroy PC, Wilhelm A, Rajwani T, Mulder M, Gosnell J, Shen WT, Duh QY, Roman S, Sosa JA. Nerve monitoring in endocrine surgery: Practice patterns differ among surgeons for parathyroidectomy and thyroidectomy. Surgery. 2024 Apr;175(4):1040-1048. doi: 10.1016/j.surg.2023.11.024. Epub 2023 Dec 21.
- Mu Y, Bian X, Yang J, Li Y, Zhang Y, Dionigi G, Zhao Y, Sun H. Recurrent laryngeal never monitoring versus non-monitoring in parathyroid surgery. Front Endocrinol (Lausanne). 2023 Nov 28;14:1299943. doi: 10.3389/fendo.2023.1299943. eCollection 2023.
- Pardal-Refoyo JL, Parente-Arias P, Arroyo-Domingo MM, Maza-Solano JM, Granell-Navarro J, Martinez-Salazar JM, Moreno-Luna R, Vargas-Yglesias E. Recommendations on the use of neuromonitoring in thyroid and parathyroid surgery. Acta Otorrinolaringol Esp (Engl Ed). 2018 Jul-Aug;69(4):231-242. doi: 10.1016/j.otorri.2017.06.005. Epub 2017 Sep 14. English, Spanish.
- Dobrinja C, Santandrea G, Giacca M, Stenner E, Ruscio M, de Manzini N. Effectiveness of Intraoperative Parathyroid Monitoring (ioPTH) in predicting a multiglandular or malignant parathyroid disease. Int J Surg. 2017 May;41 Suppl 1:S26-S33. doi: 10.1016/j.ijsu.2017.02.063.
- Khan ZF, Lew JI. Intraoperative Parathyroid Hormone Monitoring in the Surgical Management of Sporadic Primary Hyperparathyroidism. Endocrinol Metab (Seoul). 2019 Dec;34(4):327-339. doi: 10.3803/EnM.2019.34.4.327.
- Perrier N, Lang BH, Farias LCB, Poch LL, Sywak M, Almquist M, Vriens MR, Yeh MW, Shariq O, Duh QY, Yeh R, Vu T, LiVolsi V, Sitges-Serra A. Surgical Aspects of Primary Hyperparathyroidism. J Bone Miner Res. 2022 Nov;37(11):2373-2390. doi: 10.1002/jbmr.4689. Epub 2022 Oct 17.
- Bennett J, Suliburk JW, Moron FE. Osseous Manifestations of Primary Hyperparathyroidism: Imaging Findings. Int J Endocrinol. 2020 Feb 21;2020:3146535. doi: 10.1155/2020/3146535. eCollection 2020.
- Silverberg SJ, Walker MD, Bilezikian JP. Asymptomatic primary hyperparathyroidism. J Clin Densitom. 2013 Jan-Mar;16(1):14-21. doi: 10.1016/j.jocd.2012.11.005.
- Mazeh H, Sippel RS, Chen H. The role of gender in primary hyperparathyroidism: same disease, different presentation. Ann Surg Oncol. 2012 Sep;19(9):2958-62. doi: 10.1245/s10434-012-2378-3. Epub 2012 Apr 26.
- Ghani U, Assad S, Assad S. Role of Intraoperative Nerve Monitoring During Parathyroidectomy to Prevent Recurrent Laryngeal Nerve Injury. Cureus. 2016 Nov 15;8(11):e880. doi: 10.7759/cureus.880.
- Chiang FY, Wang LF, Huang YF, Lee KW, Kuo WR. Recurrent laryngeal nerve palsy after thyroidectomy with routine identification of the recurrent laryngeal nerve. Surgery. 2005 Mar;137(3):342-7. doi: 10.1016/j.surg.2004.09.008.
- Jatzko GR, Lisborg PH, Muller MG, Wette VM. Recurrent nerve palsy after thyroid operations--principal nerve identification and a literature review. Surgery. 1994 Feb;115(2):139-44.
- Arici C, Cheah WK, Ituarte PH, Morita E, Lynch TC, Siperstein AE, Duh QY, Clark OH. Can localization studies be used to direct focused parathyroid operations? Surgery. 2001 Jun;129(6):720-9. doi: 10.1067/msy.2001.114556.
- Udelsman R, Donovan PI, Sokoll LJ. One hundred consecutive minimally invasive parathyroid explorations. Ann Surg. 2000 Sep;232(3):331-9. doi: 10.1097/00000658-200009000-00005.
- Bilezikian JP, Khan AA, Potts JT Jr; Third International Workshop on the Management of Asymptomatic Primary Hyperthyroidism. Guidelines for the management of asymptomatic primary hyperparathyroidism: summary statement from the third international workshop. J Clin Endocrinol Metab. 2009 Feb;94(2):335-9. doi: 10.1210/jc.2008-1763.
- Naunheim MR, Dai JB, Rubinstein BJ, Goldberg L, Weinberg A, Courey MS. A visual analog scale for patient-reported voice outcomes: The VAS voice. Laryngoscope Investig Otolaryngol. 2019 Dec 17;5(1):90-95. doi: 10.1002/lio2.333. eCollection 2020 Feb.
- Korean Society of Laryngology, Phoniatrics and Logopedics Guideline Task Force; Ryu CH, Lee SJ, Cho JG, Choi IJ, Choi YS, Hong YT, Jung SY, Kim JW, Lee DY, Lee DK, Lee G, Lee SJ, Lee YC, Lee YS, Nam IC, Park KN, Park YM, Sung ES, Son HY, Seo IH, Lee BJ, Lim JY. Care and Management of Voice Change in Thyroid Surgery: Korean Society of Laryngology, Phoniatrics and Logopedics Clinical Practice Guideline. Clin Exp Otorhinolaryngol. 2022 Feb;15(1):24-48. doi: 10.21053/ceo.2021.00633. Epub 2021 Jun 1.
- Heikkinen M, Penttila E, Qvarnstrom M, Makinen K, Lopponen H, Karkkainen JM. Patient Self-Assessment and Acoustic Voice Analysis in Screening of Postoperative Vocal Fold Paresis and Paralysis. Scand J Surg. 2021 Dec;110(4):524-532. doi: 10.1177/14574969211007036. Epub 2021 Apr 12.
- Irvin GL 3rd, Solorzano CC, Carneiro DM. Quick intraoperative parathyroid hormone assay: surgical adjunct to allow limited parathyroidectomy, improve success rate, and predict outcome. World J Surg. 2004 Dec;28(12):1287-92. doi: 10.1007/s00268-004-7708-6. Epub 2004 Nov 11.
- Pisanu A, Porceddu G, Podda M, Cois A, Uccheddu A. Systematic review with meta-analysis of studies comparing intraoperative neuromonitoring of recurrent laryngeal nerves versus visualization alone during thyroidectomy. J Surg Res. 2014 May 1;188(1):152-61. doi: 10.1016/j.jss.2013.12.022. Epub 2013 Dec 25.
- Joliat GR, Guarnero V, Demartines N, Schweizer V, Matter M. Recurrent laryngeal nerve injury after thyroid and parathyroid surgery: Incidence and postoperative evolution assessment. Medicine (Baltimore). 2017 Apr;96(17):e6674. doi: 10.1097/MD.0000000000006674.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. februar 2024
Primær fullføring (Faktiske)
31. desember 2025
Studiet fullført (Faktiske)
31. desember 2025
Datoer for studieregistrering
Først innsendt
14. september 2026
Først innsendt som oppfylte QC-kriteriene
17. september 2026
Først lagt ut (Faktiske)
23. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i det endokrine systemet
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Otorhinolaryngologiske sykdommer
- Parathyreoidea sykdommer
- Sykdommer i kranienerve
- Laryngeale sykdommer
- Lammelse
- Vagus nervesykdommer
- Hyperparatyreose
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hyperparathyroidisme, primær
- Stemmebåndslammelse
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Kirurgiske prosedyrer, operativ
- Overvåking, fysiologisk
- Overvåking, intraoperativ
- Nevrofysiologisk overvåking
- Intraoperativ nevrofysiologisk overvåking
Andre studie-ID-numre
- IzmirKCU-PARATHYROID-IONM-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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