Hypoparathyroidism PostproceduralQoL-hPTPNCT04604808
Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life (QoL-hPTP)
An observational study of Hypoparathyroidism Postprocedural, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
Our study will evaluate the health related quality of life (HRQoL) after a thyroidectomy and the relevance of postoperative hypoparathyroidism. The patients submitted to a total thyroidectomy will be evaluated with three questionaries (SF-36, Hospital HADS and a specifically designed Likert-type questionary about the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Postprocedural
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to total thyroidectomy according to clinical practice.
Who may be able to join
- Patients submitted to total thyroidectomy
- Patients older than 18 yo
- Patients who accept participating in the study.
- Patients who, before the surgery, have done a complete laboratory test.
- Patients followed for at least one month after surgery.
Who cannot join
- Patients submitted to a subtotal or completion thyroidectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Prospective Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life (QoL-hPTP)
Our study will evaluate the health related quality of life (HRQoL) after a thyroidectomy and the relevance of postoperative hypoparathyroidism. The patients submitted to a total thyroidectomy will be evaluated with three questionaries (SF-36, Hospital HADS and a specifically designed Likert-type questionary about the intensity of hypoparathyroidism symptoms). The first evaluation will be before the surgery, and the other two will be completed a week and a month after the procedure.
Read the detailed description
Patients submitted to total thyroidectomy according to clinical practice will be invited to participate in this study. If they accept, they will have to complete three questionaries to evaluate their HRQoL: SF-36, Hospital Anxiety and Depression Scale (HADS) and a specifically designed Likert-type questionary about the intensity of hypoparathyroidism symptoms; the day before the surgery and one week and one month after it. In those cases that develop permanent hypoparathyroidism, an additional evaluation will be done 3, 6, 9 and 12 months after surgery.
Variables:
- Demographic variables: sex, age, BMI, personal background, previous treatment.
- Diagnosis variables: diagnosis, cytology (Bethesda System), preoperative laboratory values serum (albumin, glomerular filtrate rate, total and ionic calcium, phosphate, magnesium, parathormone (PTH), 25-hydroxide (OH) vitamin D, thyroid-stimulating hormone (TSH), T4, thyroid antibodies).
- Procedure variables: central compartment dissection, accidental parathyroidectomy, parathyroid autotransplant, surgery length, intraoperative complications.
- Post-operative variables:
- Laboratory test 24h after surgery: albumin, glomerular filtrate rate, total and ionic calcium, phosphate, magnesium, PTH, 25-OH vitamin D.
- Symptoms of Hypocalcemia: presence of spontaneous symptoms of hypocalcemia, such as paresthesias, and time from the surgery (measured in hours).
- Postoperative hypocalcemia: defined by a serum albumin-corrected calcium level below 8 mg/dL or by the presence of hypocalcemic symptoms that require calcium or vitamin D supplementation.
- Follow-up variables: all the patients will be evaluated one week and one month after surgery. When they develop a hypocalcemia, laboratory test will be repeated according to clinical practice. In all cases, this test will be repeated one month after surgery, together with thyroid function test. The need for oral supplementation of calcium and/or vitamin D analogs or even magnesium will be collected (doses and time needed). The definitive histological diagnosis and the number of additional parathyroid glands identified in the surgical specimen will be also collected. In cases that developed postoperative hypocalcemia, the investigators will record the time to resolution, defined as the absence of calcium or vitamin D supplementation and a PTH level above 13 pg/mL.
Statistical Analysis:
The patients will be divided into two group depending on the development of post-thyroidectomy hypoparathyroidism. The results of their HRQoL questionaries will be compared within both groups. The investigators will evaluate the influence of clinical variables on these results.
The quantitative variables that follow a normal distribution will be described by the mean and the standard deviation; and those who do not follow the normal distribution will be described by median and interquartile range. The qualitative variables will be defined by the number of events and the percentage. To know if the variable follow or not the normality the investigators will use de Kolmogorov-Smirnov test.
The quantitative variables with a normal distribution will be compared with Student t-test (if there are two means) or with ANOVA (for more than two means). To compare quantitative variables with a different distribution, the Mann-Whitney U test (2 means) or Kruskal-Wallis test (more than 2) will be use.
The association between quantitative variable with a normal distribution will be stablished by the Pearson correlation ratio; and for those who do not follow the normal distribution, with Spearman test.
χ2 test will be used to compare qualitative variables. If an absolute frequency less or equal to 5 is found in any of the contingency table cells, the Fisher's exact test will be used.
Every test will be considered if there is a minimum signification level of p<0,05.
Sample size calculation:
There is not enough published data in order to help us calculate a proper sample size. the investigators will conduce the first 40 patients as a pilot study, based on which it will estimate a definitive sample size. The investigators will take as reference the results of the SF-36 survey of the week after the surgery and a minimum difference to detect of the 10% of the punctuation.
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Health-related Quality of Life, Thyroidectomy, Postoperative hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non hypocalcemic group | Patients that don't develop post-thyroidectomy hypocalcemia | |
| Hypocalcemic group | Patients that develop post-thyroidectomy hypocalcemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SF-36 score
36-Item Short Form Health Survey questionnaire: 0 to 100 points, been a lower score a worse outcome
Measured: Preoperative, one week and one month after surgery
Change in HADS score
Hospital Anxiety and Depression Scale: 0 to 42 points, been a higher score a worse outcome
Measured: Preoperative, one week and one month after surgery
Changes Questionary of hypocalcemia symptoms
Specifical designed Liker-type questionary: Likert scale based score, from 1 to 10 points, been a higher score a worse outcome
Measured: Preoperative, one week and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism PostproceduralStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Muñoz de Nova, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604808
- Sponsor's protocol ID
- QoL-hPTP
- Acronym
- QoL-hPTP
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life (QoL-hPTP)
- ClinicalTrials.gov ID
- NCT04604808
- Acronym / sponsor ID
- QoL-hPTP / QoL-hPTP
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Health-related Quality of Life, Thyroidectomy, Postoperative hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 Oct 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.
Our study will evaluate the health related quality of life (HRQoL) after a thyroidectomy and the relevance of postoperative hypoparathyroidism. The patients submitted to a total thyroidectomy will be evaluated with three questionaries (SF-36, Hospital HADS and a specifically designed Likert-type questionary about the intensity of hypoparathyroidism symptoms). The first evaluation will be before the surgery, and the other two will be completed a week and a month after the procedure.
Detailed description
Patients submitted to total thyroidectomy according to clinical practice will be invited to participate in this study. If they accept, they will have to complete three questionaries to evaluate their HRQoL: SF-36, Hospital Anxiety and Depression Scale (HADS) and a specifically designed Likert-type questionary about the intensity of hypoparathyroidism symptoms; the day before the surgery and one week and one month after it. In those cases that develop permanent hypoparathyroidism, an additional evaluation will be done 3, 6, 9 and 12 months after surgery.
Variables:
- Demographic variables: sex, age, BMI, personal background, previous treatment.
- Diagnosis variables: diagnosis, cytology (Bethesda System), preoperative laboratory values serum (albumin, glomerular filtrate rate, total and ionic calcium, phosphate, magnesium, parathormone (PTH), 25-hydroxide (OH) vitamin D, thyroid-stimulating hormone (TSH), T4, thyroid antibodies).
- Procedure variables: central compartment dissection, accidental parathyroidectomy, parathyroid autotransplant, surgery length, intraoperative complications.
- Post-operative variables:
- Laboratory test 24h after surgery: albumin, glomerular filtrate rate, total and ionic calcium, phosphate, magnesium, PTH, 25-OH vitamin D.
- Symptoms of Hypocalcemia: presence of spontaneous symptoms of hypocalcemia, such as paresthesias, and time from the surgery (measured in hours).
- Postoperative hypocalcemia: defined by a serum albumin-corrected calcium level below 8 mg/dL or by the presence of hypocalcemic symptoms that require calcium or vitamin D supplementation.
- Follow-up variables: all the patients will be evaluated one week and one month after surgery. When they develop a hypocalcemia, laboratory test will be repeated according to clinical practice. In all cases, this test will be repeated one month after surgery, together with thyroid function test. The need for oral supplementation of calcium and/or vitamin D analogs or even magnesium will be collected (doses and time needed). The definitive histological diagnosis and the number of additional parathyroid glands identified in the surgical specimen will be also collected. In cases that developed postoperative hypocalcemia, the investigators will record the time to resolution, defined as the absence of calcium or vitamin D supplementation and a PTH level above 13 pg/mL.
Statistical Analysis:
The patients will be divided into two group depending on the development of post-thyroidectomy hypoparathyroidism. The results of their HRQoL questionaries will be compared within both groups. The investigators will evaluate the influence of clinical variables on these results.
The quantitative variables that follow a normal distribution will be described by the mean and the standard deviation; and those who do not follow the normal distribution will be described by median and interquartile range. The qualitative variables will be defined by the number of events and the percentage. To know if the variable follow or not the normality the investigators will use de Kolmogorov-Smirnov test.
The quantitative variables with a normal distribution will be compared with Student t-test (if there are two means) or with ANOVA (for more than two means). To compare quantitative variables with a different distribution, the Mann-Whitney U test (2 means) or Kruskal-Wallis test (more than 2) will be use.
The association between quantitative variable with a normal distribution will be stablished by the Pearson correlation ratio; and for those who do not follow the normal distribution, with Spearman test.
χ2 test will be used to compare qualitative variables. If an absolute frequency less or equal to 5 is found in any of the contingency table cells, the Fisher's exact test will be used.
Every test will be considered if there is a minimum signification level of p<0,05.
Sample size calculation:
There is not enough published data in order to help us calculate a proper sample size. the investigators will conduce the first 40 patients as a pilot study, based on which it will estimate a definitive sample size. The investigators will take as reference the results of the SF-36 survey of the week after the surgery and a minimum difference to detect of the 10% of the punctuation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non hypocalcemic group | – | –Patients that don't develop post-thyroidectomy hypocalcemia |
| Hypocalcemic group | – | –Patients that develop post-thyroidectomy hypocalcemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to total thyroidectomy according to clinical practice.
Key inclusion criteria (5 listed)
- Patients submitted to total thyroidectomy
- Patients older than 18 yo
- Patients who accept participating in the study.
- Patients who, before the surgery, have done a complete laboratory test.
- Patients followed for at least one month after surgery.
Key exclusion criteria (1 listed)
- Patients submitted to a subtotal or completion thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in SF-36 score
Time frame: Preoperative, one week and one month after surgery
36-Item Short Form Health Survey questionnaire: 0 to 100 points, been a lower score a worse outcome
Change in HADS score
Time frame: Preoperative, one week and one month after surgery
Hospital Anxiety and Depression Scale: 0 to 42 points, been a higher score a worse outcome
Changes Questionary of hypocalcemia symptoms
Time frame: Preoperative, one week and one month after surgery
Specifical designed Liker-type questionary: Likert scale based score, from 1 to 10 points, been a higher score a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoparathyroidism Postprocedural, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SF-36 score (time frame: Preoperative, one week and one month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.