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

Umraniye Education and Research Hospital

Status: Unknown

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

Treatments: Procedure: Total thyroidectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04396912

B.10.1TKH.4.34.H.GP0.01/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 4 patient groups

Control, s/p TT, without complication

Description:

Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched)

Treatment:

Procedure: Total thyroidectomy

Experimental, s/p TT with only VCP

Description:

Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral)

Treatment:

Procedure: Total thyroidectomy

Experimental, s/p TT with only H

Description:

Experimental (s/p TT, with only hypocalcemia-H, transient or permanent)

Treatment:

Procedure: Total thyroidectomy

Experimental, s/p TT with both VCP+H

Description:

Experimental (s/p TT, with both vocal cord paralysis-VCP and hypocalcemia-H); Subgroups: 4.1. VCP (Permanent) + H (Permanent) 4.2. VCP (Transient) + H (Transient) 4.3. VCP (Permanent) + H (Transient) 4.4. VCP (Transient) + H (Permanent) Please answer: * 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? (any objective sign? Ca? PTH?

Treatment:

Procedure: Total thyroidectomy