Iatrogenic HypocalcemiaNCT04396912
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
An observational study of Iatrogenic Hypocalcemia and Iatrogenic Hypoparathyroidism, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Iatrogenic Hypocalcemia, Iatrogenic Hypoparathyroidism, Vocal Cord Paralysis
- What is being tested?
- Total thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with benign or malign thyroid diseases, eligable for total thyroidectomy
Who may be able to join
- 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
Who cannot join
- Patients with recurrent thyroid disease (benign/malign), prepared for a second operation
- Preferance of thyroid surgery other than total thyroidectomy
Trial locations and contacts
1 site in 1 country.
Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Education and Research Hospital, Health Sciences University
Istanbul, 34764
Ethem UNAL, MD, PhD, USMLE & IFSO- Certified Board CSS, 0090(216)6321818 ext. 1951, drethemunal@gmail.com
Kadir M YILDIRAK, MD, 0090(216)6321818 ext. 1951, kadiryildira@gmail.com
About this study
Official title: Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines
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.
Read the 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
- Being tested
- Total thyroidectomy
- Keywords
- Total thyroidectomy
- Medical subject headings
- Vocal Cord Paralysis, Wounds and Injuries, Thyroid Cancer, Papillary, Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control, s/p TT, without complication | Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched) Receives: Procedure: Total thyroidectomy | |
| Experimental, s/p TT with only VCP | Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral) Receives: Procedure: Total thyroidectomy | |
| Experimental, s/p TT with only H | Experimental (s/p TT, with only hypocalcemia-H, transient or permanent) Receives: 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? Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
s/p TT- normal (no complication)
TT: total thyroidectomy
Measured: June 01, 2020-June 01, 2021
s/p TT+VCP
VCP: vocal cord paralysis
Measured: June 01, 2020-June 01, 2021
s/p TT+H
H: hypocalcemia
Measured: June 01, 2020-June 01, 2021
s/p TT+VCP+H
Any improvement recorded? VCP? H? vice versa
Measured: June 01, 2020-June 01, 2021
Secondary outcomes (1)
Improvement in vocal cord function /serum calcium
VCP+H
Measured: June 01, 2020-June 01, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start15 May 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic HypocalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic, Umraniye Education and Research Hospital
- Investigators
- Sema YUKSEKDAG, MD, Principal investigator, Instructor in General SurgeryEthem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS, Study chair, Assoc. Professor of General Surgery and Surgical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396912
- Sponsor's protocol ID
- B.10.1TKH.4.34.H.GP0.01/1
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study is open to high-volume INTERNATIONAL endocrine surgery centers, eager to join to present STROBE compatible observational study Available upon email requests@drethemunal@gmail.com
Publications
Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18.
PubMed 30930717Giulea 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.
PubMed 31670633
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines
- ClinicalTrials.gov ID
- NCT04396912
- Acronym / sponsor ID
- B.10.1TKH.4.34.H.GP0.01/1
- Conditions
- Iatrogenic Hypocalcemia, Iatrogenic Hypoparathyroidism, Vocal Cord Paralysis, Vocal Cord Paresis, Vocal Cord; Injury, Superficial, Thyroid Cancer, Papillary
- Keywords
- Total thyroidectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control, s/p TT, without complication | – | Procedure: Total thyroidectomyControl (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched) |
| Experimental, s/p TT with only VCP | – | Procedure: Total thyroidectomyExperimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral) |
| Experimental, s/p TT with only H | – | Procedure: Total thyroidectomyExperimental (s/p TT, with only hypocalcemia-H, transient or permanent) |
| Experimental, s/p TT with both VCP+H | – | Procedure: Total thyroidectomyExperimental (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? |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with benign or malign thyroid diseases, eligable for total thyroidectomy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with recurrent thyroid disease (benign/malign), prepared for a second operation
- Preferance of thyroid surgery other than total thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total thyroidectomyPatients 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. | Procedure or surgery | 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 |
Primary outcome
s/p TT- normal (no complication)
Time frame: June 01, 2020-June 01, 2021
TT: total thyroidectomy
s/p TT+VCP
Time frame: June 01, 2020-June 01, 2021
VCP: vocal cord paralysis
s/p TT+H
Time frame: June 01, 2020-June 01, 2021
H: hypocalcemia
s/p TT+VCP+H
Time frame: June 01, 2020-June 01, 2021
Any improvement recorded? VCP? H? vice versa
1 secondary outcome
Improvement in vocal cord function /serum calcium
Time frame: June 01, 2020-June 01, 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Results publication: PubMed 30930717Cuschieri S. The STROBE guidelines. Saudi J Anaesth. 2019 Apr;13(Suppl 1):S31-S34. doi: 10.4103/sja.SJA_543_18.
- Results publication: PubMed 31670633Giulea 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.
- STROBE guidelinesLink provided by the sponsor.
- Ethem Unal, MD, PhD (h-inde 18, i10-index 33)Link provided by the sponsor.
- VCPLink provided by the sponsor.
- TT complicationsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study is open to high-volume INTERNATIONAL endocrine surgery centers, eager to join to present STROBE compatible observational study Available upon email requests@drethemunal@gmail.com
Related trials for Iatrogenic Hypocalcemia
Recruiting
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
Iatrogenic Hypocalcemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS contact
Sema YUKSEKDAG, MD principal investigator
Instructor in General Surgery
Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS study chair
Assoc. Professor of General Surgery and Surgical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Hypocalcemia and Iatrogenic Hypoparathyroidism, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS (0090(216)6321818 ext. 1951, drethemunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
s/p TT- normal (no complication) (time frame: June 01, 2020-June 01, 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04396912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.