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

NCT ID: NCT04396912

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-06-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control, s/p TT, without complication

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

Total thyroidectomy

Intervention Type: PROCEDURE

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.

Experimental, s/p TT with only VCP

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

Total thyroidectomy

Intervention Type: PROCEDURE

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.

Experimental, s/p TT with only H

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

Total thyroidectomy

Intervention Type: PROCEDURE

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.

Experimental, s/p TT with both VCP+H

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?

Total thyroidectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic

MD, PhD, USMLE & IFSO-Certified, BCSS, Associated Professor of General Surgery and Surgical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sema YUKSEKDAG, MD

Role: PRINCIPAL_INVESTIGATOR

Instructor in General Surgery

Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS

Role: STUDY_CHAIR

Assoc. Professor of General Surgery and Surgical Oncology

Locations

Umraniye Education and Research Hospital, Health Sciences University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS

Role: CONTACT

drethemunal@gmail.com

0090(216)6321818 ext. 1951

Kadir YILDIRAK, MD

Role: CONTACT

kadiryildira@gmail.com

0090(216)6321818 ext. 1951

Facility Contacts

Ethem UNAL, MD, PhD, USMLE & IFSO- Certified Board CSS

Role: primary

drethemunal@gmail.com

0090(216)6321818 ext. 1951

Kadir M YILDIRAK, MD

Role: backup

kadiryildira@gmail.com

0090(216)6321818 ext. 1951

References

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

Reference Type: RESULT

PMID: 30930717 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31670633 (View on PubMed)

Related Links

https://www.equator-network.org/reporting-guidelines/strobe/

STROBE guidelines

https://scholar.google.com.tr/citations?user=6bFlCZwAAAAJ&hl=tr

Ethem Unal, MD, PhD (h-inde 18, i10-index 33)

https://www.journalagent.com/ejm/pdfs/EJM-33254-ORIGINAL_ARTICLE-YUKSEKDAG.pdf

VCP

https://books.google.com.tr/books?id=MQX59bsB3CwC&pg=PA606&lpg=PA606&dq=recurrent+nerve+palsy+concurrent+hypocalcemia&source=bl&ots=H0OYiolBHv&sig=ACfU3U1_6EiiCEJ0mBCLikHDHHsoniUxkA&hl=tr&sa=X&ved=2ahUKEwiQpePr_rbpAhUlxMQBHYZdBWYQ6AEwAXoECAUQAQ#v=onepage&q=recurrent%20nerve%20palsy%20concurrent%20hypocalcemia&f=false

TT complications

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id