Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma
17 september 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
İzmir
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Izmir, İzmir, Turkiet (Türkiye), 35100
- Izmir Katip Celebi University Ataturk Training and Research Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: IONM GROUP
Patients undergoing parathyroid surgery with intraoperative neuromonitoring. |
INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION. |
|
Inget ingripande: NON-IONM GROUP
Patients undergoing parathyroid surgery without intraoperative neuromonitoring. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: MEHMET HACIYANLI, MD, Izmir Katip Celebi University Ataturk Training and Research Hospital
- Huvudutredare: MERT YOLDAŞ, Izmir Katip Celebi University Ataturk Training and Research Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 februari 2024
Primärt slutförande (Faktisk)
31 december 2025
Avslutad studie (Faktisk)
31 december 2025
Studieregistreringsdatum
Först inskickad
14 september 2026
Först inskickad som uppfyllde QC-kriterierna
17 september 2026
Första postat (Faktisk)
23 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i det endokrina systemet
- Sjukdomar i nervsystemet
- Luftvägssjukdomar
- Otorhinolaryngologiska sjukdomar
- Paratyreoidea sjukdomar
- Kranial nervsjukdomar
- Larynxsjukdomar
- Förlamning
- Vagus nervsjukdomar
- Hyperparatyreos
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Hyperparatyreos, primär
- Stämbandsförlamning
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Övervakning, fysiologisk
- Övervakning, intraoperativ
- Neurofysiologisk övervakning
- Intraoperativ neurofysiologisk övervakning
Andra studie-ID-nummer
- IzmirKCU-PARATHYROID-IONM-001
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