Clinical trial NCT04396912: Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
Official title: Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iatrogenic Hypocalcemia
Iatrogenic Hypoparathyroidism
Vocal Cord Paralysis
Vocal Cord Paresis
Vocal Cord; Injury, Superficial
Thyroid Cancer, Papillary
Thyroid Cancer
Multinodular Goiter
Thyroid Neoplasms
Thyroid Nodule
Calcium Deficiency
PTH
Keywords: Total thyroidectomy
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with benign or malign thyroid diseases, eligable for 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.

Eligibility criteria: 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

Primary outcomes:
measure: s/p TT- normal (no complication)
timeFrame: June 01, 2020-June 01, 2021
measure: s/p TT+VCP
timeFrame: June 01, 2020-June 01, 2021
measure: s/p TT+H
timeFrame: June 01, 2020-June 01, 2021
measure: s/p TT+VCP+H
timeFrame: June 01, 2020-June 01, 2021
Secondary outcomes:
measure: Improvement in vocal cord function /serum calcium
timeFrame: June 01, 2020-June 01, 2021
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital, Health Sciences University
Study officials:
affiliation: Instructor in General Surgery
name: Sema YUKSEKDAG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assoc. Professor of General Surgery and Surgical Oncology
name: Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS
role: STUDY_CHAIR
References:
citation: Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18.
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):579-585. doi: 10.21614/chirurgia.114.5.579.