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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04396912
• Other study ID #: B.10.1TKH.4.34.H.GP0.01/1
• Status: Recruiting
• Start date: May 15, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2020
• Source: Umraniye Education and Research Hospital
• Contact: Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS
• Phone: 0090(216)6321818
• Email: drethemunal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Total 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.

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital, Health Sciences University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18. Review. — View Citation

Giulea C, Enciu O, Toma EA, Calu V, Miron A. The Tubercle of Zuckerkandl is Associated with Increased Rates of Transient Postoperative Hypocalcemia and Recurrent Laryngeal Nerve Palsy After Total Thyroidectomy. Chirurgia (Bucur). 2019 Sept-Oct;114(5):579- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	s/p TT- normal (no complication)	TT: total thyroidectomy	June 01, 2020-June 01, 2021
Primary	s/p TT+VCP	VCP: vocal cord paralysis	June 01, 2020-June 01, 2021
Primary	s/p TT+H	H: hypocalcemia	June 01, 2020-June 01, 2021
Primary	s/p TT+VCP+H	Any improvement recorded? VCP? H? vice versa	June 01, 2020-June 01, 2021
Secondary	Improvement in vocal cord function /serum calcium	VCP+H	June 01, 2020-June 01, 2021

External Links

•   Ethem Unal, MD, PhD (h-inde 18, i10-index 33)
•   STROBE guidelines
•   TT complications
•   VCP