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

NCT04396912 | Unknown DMC

• 1 other identifier: B.10.1TKH.4.34.H.GP0.01/1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• s/p TT- normal (no complication)

  TT: total thyroidectomy

  June 01, 2020-June 01, 2021

• s/p TT+VCP

  VCP: vocal cord paralysis

  June 01, 2020-June 01, 2021

• s/p TT+H

  H: hypocalcemia

  June 01, 2020-June 01, 2021

• s/p TT+VCP+H

  Any improvement recorded? VCP? H? vice versa

  June 01, 2020-June 01, 2021

Secondary Outcomes (1)

• Improvement in vocal cord function /serum calcium

  June 01, 2020-June 01, 2021

Study Arms (4)

Control, s/p TT, without complication

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

Procedure: Total thyroidectomy

Experimental, s/p TT with only VCP

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

Procedure: Total thyroidectomy

Experimental, s/p TT with only H

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

Procedure: Total thyroidectomy

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?

Procedure: Total thyroidectomy

Interventions

Total thyroidectomy 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.

Control, s/p TT, without complication; Experimental, s/p TT with both VCP+H; Experimental, s/p TT with only H; Experimental, s/p TT with only VCP

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with benign or malign thyroid diseases, eligable for total thyroidectomy

You may qualify if:

• 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

You may not qualify if:

• Patients with recurrent thyroid disease (benign/malign), prepared for a second operation
• Preferance of thyroid surgery other than total thyroidectomy

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital, Health Sciences University

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Related Publications (2)

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

  PMID: 30930717 RESULT

• 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.

  PMID: 31670633 RESULT

Related Links

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

MeSH Terms

Conditions

Vocal Cord Paralysis; Wounds and Injuries; Thyroid Cancer, Papillary; Thyroid Neoplasms; Thyroid Nodule

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Sema YUKSEKDAG, MD

  Instructor in General Surgery

  PRINCIPAL INVESTIGATOR

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

  Assoc. Professor of General Surgery and Surgical Oncology

  STUDY CHAIR

Central Study Contacts

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

CONTACT

0090(216)6321818; drethemunal@gmail.com

Kadir YILDIRAK, MD

CONTACT

0090(216)6321818; kadiryildira@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, USMLE & IFSO-Certified, BCSS, Associated Professor of General Surgery and Surgical Oncology

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From June 01, 2020, for 6 months
• Access Criteria: Contact to drethemunal@gmail.com

Locations

TU (1)