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

• Conditions: Iatrogenic Hypocalcemia; Thyroid Cancer, Papillary; PTH; Vocal Cord; Injury, Superficial; Multinodular Goiter; Thyroid Nodule; Iatrogenic Hypoparathyroidism; Vocal Cord Paralysis; Vocal Cord Paresis; Thyroid Neoplasms
• Interventions: Procedure: Total thyroidectomy

• Registration Number: NCT04396912
• Lead Sponsor: Umraniye Education and Research Hospital

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-15
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Last Update Submitted: 2020-05-15
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control, s/p TT, without complication	Total thyroidectomy	Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched)
Experimental, s/p TT with only H	Total thyroidectomy	Experimental (s/p TT, with only hypocalcemia-H, transient or permanent)
Experimental, s/p TT with both VCP+H	Total thyroidectomy	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?
Experimental, s/p TT with only VCP	Total thyroidectomy	Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in vocal cord function /serum calcium	June 01, 2020-June 01, 2021	VCP+H

Trial Locations

Locations (1)

Umraniye Education and Research Hospital, Health Sciences University; 🇹🇷 Istanbul, Turkey