Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid AdenomaNCT07836335

Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma

A study testing INTRAOPERATIVE NEUROMONITORING in people with Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma
What is being tested?: INTRAOPERATIVE NEUROMONITORING
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 21 Feb 2024to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Izmir Katip Celebi University Ataturk Training and Research Hospital
Izmir, İzmir, 35100

Other trials in Turkey (Türkiye)

About this study

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.

Conditions: Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma
Being tested: INTRAOPERATIVE NEUROMONITORING
Keywords: IONM, parathyroidectomy, primary hyperparathyroidism, vocal cord paralysis
Medical subject headings: Hyperparathyroidism, Primary, Vocal Cord Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INTRAOPERATIVE NEUROMONITORINGProcedure or surgery
INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION.

Study groups in NCT07836335
Study group	Role	What they receive
IONM GROUP	Experimental	Patients undergoing parathyroid surgery with intraoperative neuromonitoring. Receives: Procedure: INTRAOPERATIVE NEUROMONITORING
NON-IONM GROUP	No intervention	Patients undergoing parathyroid surgery without intraoperative neuromonitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
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
Measured: Postoperative Day 1 and 1 Week After Surgery

Secondary outcomes (3)

Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
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.
Measured: 10th minute after parathyroidectomy
Operative Time, Reported in Minutes
Operative time will be measured from the beginning of the surgical incision to completion of skin closure and will be reported in minutes.
Measured: During surgery
Incision Length, Reported in Millimeters
The length of the surgical incision will be measured at the end of the surgical procedure and reported in millimeters.
Measured: At the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202431 Dec 2025

First posted23 Sep 2026
Study start21 Feb 2024
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid AdenomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07836335
Sponsor's protocol ID: IzmirKCU-PARATHYROID-IONM-001
Status last verified: Sep 2026
First submitted: 14 Sep 2026
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41832278
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.
PubMed 38732275
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.
PubMed 38135552
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.
PubMed 38089613
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.
PubMed 28917827
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.
PubMed 28506410
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.
PubMed 31884732
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.
PubMed 36054175
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.
PubMed 32148487
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.
PubMed 23374736
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.
PubMed 22535262
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.
PubMed 28003944
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.
PubMed 15746790
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.
PubMed 8310401

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma
ClinicalTrials.gov ID: NCT07836335
Acronym / sponsor ID: IzmirKCU-PARATHYROID-IONM-001
Conditions: Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma
Keywords: IONM, parathyroidectomy, primary hyperparathyroidism, vocal cord paralysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Izmir Katip Celebi UniversityUniversity, hospital or other
Study start: 21 Feb 2024 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 23 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IONM GROUP	Experimental	Procedure: INTRAOPERATIVE NEUROMONITORINGPatients undergoing parathyroid surgery with intraoperative neuromonitoring.
NON-IONM GROUP	No intervention	–Patients undergoing parathyroid surgery without intraoperative neuromonitoring.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INTRAOPERATIVE NEUROMONITORINGINTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION.	Procedure or surgery	IONM GROUP

Primary outcome

Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
Time frame: 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

3 secondary outcomes

Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
Time frame: 10th minute after parathyroidectomy
Operative Time, Reported in Minutes
Time frame: During surgery
Incision Length, Reported in Millimeters
Time frame: At the end of surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Backgroundandolph GW, editor. Surgery of the thyroid and parathyroid glands. 3rd ed. Philadelphia: Elsevier; 2021.
Background: PubMed 41832278Duran-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.
Background: PubMed 38732275Saxe 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.
Background: PubMed 38135552Conroy 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.
Background: PubMed 38089613Mu 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.
Background: PubMed 28917827Pardal-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.
Background: PubMed 28506410Dobrinja 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.
Background: PubMed 31884732Khan 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.
Background: PubMed 36054175Perrier 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.
Background: PubMed 32148487Bennett 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.
Background: PubMed 23374736Silverberg 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.
Background: PubMed 22535262Mazeh 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MEHMET HACIYANLI, MD study director

Izmir Katip Celebi University Ataturk Training and Research Hospital

MERT YOLDAŞ principal investigator

Izmir Katip Celebi University Ataturk Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction (time frame: Postoperative Day 1 and 1 Week After Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836335, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.