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Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort

Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04396912
Enrollment
100
Registered
2020-05-21
Start date
2020-05-15
Completion date
2021-06-01
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium Deficiency, Iatrogenic Hypocalcemia, Iatrogenic Hypoparathyroidism, Multinodular Goiter, PTH, Thyroid Cancer, Thyroid Cancer, Papillary, Thyroid Neoplasms, Thyroid Nodule, Vocal Cord; Injury, Superficial, Vocal Cord Paralysis, Vocal Cord Paresis

Keywords

Total thyroidectomy

Brief summary

In the present study, the severity of recurrent laryngeal nerve injury (RLNI) and hypocalcemia (H) will be followed-up and the probable interrelation between them will be proposed considering the clinical situation of patients, e.g. improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?), return of voice is parallel with the improvement in hypocalcemia? Postoperative calcium (Ca), parathyroid hormone (PTH), regular vocal cord evaluations by ear-nose-throat (ENT) exams, deterioration-stability-improvement of clinical symptoms regarding both Ca metabolism and vocal cord function will be noted at regular intervals (postoperative day 1-3-first, weekly control/first month, monthly/first 6-month, 3-monthly/6-12 months) at outpatient controls. Serum Ca, PTH, ENT evaluation of vocal cords-noted.

Detailed description

Total thyroidectomy is currently the preferred surgical treatment modality for both thyroid carcinomas and benign disorders such as multinodular goitre, since it minimizes the risk of recurrence and eliminates the complication risks of repeat or completion surgery. Vocal cord paralysis due to injury to recurrent laryngeal nerve (RLN) is the most dreaded complication of total thyroidectomy. The reported incidence of temporary RLN injury (RLNI) varies between 0 and 12 %, while the incidence of permanent RLNI has been reported to be much lower (0-3.5 %). In case of bilateral RLNI, respiratory distress and aspiration can develop rapidly and may result in mortality. Therefore, all precautions including close monitoring and tracheostomy should be undertaken without any delay. The best known technique to avoid injury to RLN is meticulous dissection of the nerve throughout its anatomic pathway. However, functional impairment of RLN is not visible macroscopically and intraoperative nerve monitoring (IONM) has been developed to monitor the nerve to avoid unnecessary dissection. Meticulous hemostasis can be achieved with harmonic sealing instrument, since improper hemostasis is known to increase the risk of RLNI. Despite the lack of evidence to support an advantage of IONM over the standard anatomic dissection of RLN, surgeons have adopted it in increasing ratios. The second most feared compliation of thyroidectomy is iatrogenic hypocalcemia. Transient symptomatic hypocalcemia after total thyroidectomy occurs in approximately 7% to 25% of cases, but permanent hypocalcemia is less common (0.4% to 13.8%). Size and invasion of tumor, operative trauma and vascular compromise determines the severity of symptoms.

Interventions

PROCEDURETotal thyroidectomy

Patients with thyroid diseases either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) will be prepared for total thyroidectomy procedure and will be enrolled.

Sponsors

Umraniye Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with total thyroidectomy indication, for either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) thyroid disease * \>17 year-old * Available for close follow-ups at outpatient clinic * Available for close vocal cord exams

Exclusion criteria

* Patients with recurrent thyroid disease (benign/malign), prepared for a second operation * Preferance of thyroid surgery other than total thyroidectomy

Design outcomes

Primary

MeasureTime frameDescription
s/p TT- normal (no complication)June 01, 2020-June 01, 2021TT: total thyroidectomy
s/p TT+VCPJune 01, 2020-June 01, 2021VCP: vocal cord paralysis
s/p TT+HJune 01, 2020-June 01, 2021H: hypocalcemia
s/p TT+VCP+HJune 01, 2020-June 01, 2021Any improvement recorded? VCP? H? vice versa

Secondary

MeasureTime frameDescription
Improvement in vocal cord function /serum calciumJune 01, 2020-June 01, 2021VCP+H

Countries

Turkey (Türkiye)

Contacts

Primary ContactEthem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS
drethemunal@gmail.com0090(216)6321818
Backup ContactKadir YILDIRAK, MD
kadiryildira@gmail.com0090(216)6321818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026