Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04604808 |
| Other study ID # |
QoL-hPTP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
