Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma
17 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
İzmir
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Izmir, İzmir, Turchia (Türkiye), 35100
- Izmir Katip Celebi University Ataturk Training and Research Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: IONM GROUP
Patients undergoing parathyroid surgery with intraoperative neuromonitoring. |
INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION. |
|
Nessun intervento: NON-IONM GROUP
Patients undergoing parathyroid surgery without intraoperative neuromonitoring. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
Lasso di tempo: Postoperative Day 1 and 1 Week After Surgery
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At the end of surgery
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: MEHMET HACIYANLI, MD, Izmir Katip Celebi University Ataturk Training and Research Hospital
- Investigatore principale: MERT YOLDAŞ, Izmir Katip Celebi University Ataturk Training and Research Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- 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.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
21 febbraio 2024
Completamento primario (Effettivo)
31 dicembre 2025
Completamento dello studio (Effettivo)
31 dicembre 2025
Date di iscrizione allo studio
Primo inviato
14 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 settembre 2026
Primo Inserito (Effettivo)
23 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema endocrino
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Malattie otorinolaringoiatriche
- Malattie paratiroidee
- Malattie dei nervi cranici
- Malattie laringee
- Paralisi
- Malattie del nervo vago
- Iperparatiroidismo
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Iperparatiroidismo, primario
- Paralisi delle corde vocali
- Tecniche e procedure diagnostiche
- Diagnosi
- Procedure chirurgiche, operative
- Monitoraggio, fisiologico
- Monitoraggio, intraoperatorio
- Monitoraggio neurofisiologico
- Monitoraggio neurofisiologico intraoperatorio
Altri numeri di identificazione dello studio
- IzmirKCU-PARATHYROID-IONM-001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .