Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604808
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2020-09-29
Brief Title:
Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life QoL-hPTP
Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
Observational Prospective Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life QoL-hPTP
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QoL-hPTP
Brief 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 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 mgdL 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 andor 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 pgmL
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 Fishers exact test will be used
Every test will be considered if there is a minimum signification level of p005
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
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 mgdL 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 andor 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 pgmL
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 Fishers exact test will be used
Every test will be considered if there is a minimum signification level of p005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None