The aim of this study is to evaluate the use of rapid IO-PTH measurement to predict post-thyroidectomy hypocalciemia.
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
postoperative serum calcium corrected for albumin levels.
Secondary outcome
- patient characteristics
- pre- intra- and postoperative PTH levels
- reported symptoms of hypocalcemia
- operation report
- pathology report
- length of hopsital stay
- type and dosage of calcium suppletion
Background summary
Hypocalcemia is the most common complication in patients undergoing total
thyroidectomy. The cause of postoperative hypocalcemia is iatrogenic damage or
resection of the parathyroid glands, which are anatomically closely related to
the thyroid gland. Currently, postoperatively, calcium is only measured 6 hours
after surgery and patients receive calcium suppletion when hypocalcaemia is
detected or when the patient experiences symptoms. This causes a delay in
treatment, and hospital stay is often prolonged. On the other hand,
prophylactic calcium suppletion causes unnecessary overtreatment. Measuring the
cause of hypocalcemia, hypoparathyroidism, during thyroid surgery, might
provide a risk stratification of which patients will develop postoperative
hypocalcemia and which will not. Intraoperative PTH measurement is currently
only applied in parathyroid surgery, to determine the success of the operation.
We would like to investigate the feasibility of using fast intra-operative PTH
measurement to predict postoperative hypocalcemia. In the future, we might be
able to prevent hypocalcemia in patients who are determined at risk during
thyroid surgery.
Study objective
The aim of this study is to evaluate the use of rapid IO-PTH measurement to
predict post-thyroidectomy hypocalciemia.
Study design
Prospective cohort validation and feasibility study.
Study burden and risks
Burden: very low. 6x 6ml blood will be drawn during operation via standard i.v.
access which every patient will receive.
Risks: no, there will be no consequences of the intraoperative findings. The
surgery and/or postoperative treatment will not change.
Future patient will hopefully benefit from the findings of this study.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing total thyroidectomy or;
- Patients undergoing completion thyroidectomy after previous
hemithyroidectomy; and
- 25-OH vitamin D within the normal range
- *18 years and;
- Capable of understanding Dutch language and;
- Signed informed consent
Exclusion criteria
- Patients undergoing hemithyroidectomy
- Known parathyroid disease , e.g. hyperparathyroidism or hypoparathyroidism
- End-stage renal disease or kidney transplantation
- Use of calcium suppletion
- Use of lithium medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69010.042.19 |
| Other | UTOPIA201800653 |