The aim of our study is to investigate whether PTH levels measured between 4-24 hours after surgery can accurately identify patients with permanent hypoparathyroidism after thyroid surgery who need long-term calcium supplementation.
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can we use PTH levels obtained directly after surgery to predict which patient
will remain hypocalciaemic?
Secondary outcome
Not applicable
Background summary
Total thyroidectomy is the operation of choice for many patients with thyroid
carcinoma, and sometimes with Graves* disease or multinodular goitre.
Postoperative hypoparathyroidism, following total thyroidectomy is a common
iatrogenic complication leading, among other factors, to hypocalcaemia. Up to
55-60% of the patients develop serum calcium levels below 2.00 mmol/L on the
first day after surgery. Therefore it is routine practice to monitor patients
clinically for signs and symptoms of hypocalcaemia as well as perform regular
measurements of serum calcium levels. Recent studies (2,3) have shown that a
serum parathyroid hormone (PTH) concentration obtained 4-24 hours
postoperatively is the most significant factor to predict postoperative
hypocalcaemia. In most patients with post-thyroidectomy hypocalcaemia,
parathyroid function (if any glands are left) restores within several weeks.
However, up to 5-10% of the patients may develop persistent hypoparathyroidism
and require lifelong calcium supplementation. In a study by Sitges-Serra et
al.1 evaluating 442 patients after total thyroidectomy, 222 patients had
postoperative hypocalcaemia. Of them, 40% (80/222 patients) still had
hypocalcaemia one month after surgery. PTH levels were also measured one month
after surgery: 90% (40/44 patients) of the patients with low PTH levels
recovered to normal parathyroid function within one year compared with 62% of
the patients with undetectable parathyroid levels (21/34 patients). Logistic
regression analysis identified undetectable PTH levels one month after surgery
to predict permanent failure of parathyroid function. However, PTH levels
directly after surgery were not measured. We aim to identify a predictive
factor for persistent hypoparathyroidism after a total (or completion)
thyroidectomy that can be obtained directly after surgery. This would not only
be valuable for planning outpatient appointments, but would also provide more
certainty for the patient. In addition calcium supplementation can become more
patient tailored at the outpatient department, aiming to reduce the negative
consequences of hypocalcaemia, unnecessary visits and laboratory
investigations. Therefore the aim of our study is to investigate whether PTH
levels measured between 4-242,3 hours after surgery will identify patients who
need long-term calcium supplementation.
Study objective
The aim of our study is to investigate whether PTH levels measured between 4-24
hours after surgery can accurately identify patients with permanent
hypoparathyroidism after thyroid surgery who need long-term calcium
supplementation.
Study design
This extra protocol applies to all patients who have given informed consent.
1. Prior to surgery (outpatient department), (Day -1)
a. Check informed consent and contact with study coordinator
b. Lab (t=0): Routine laboratory screening, including: calcium/
phosphate/albumin/vitamin D including: PTH for the study
2. Day of surgery (Day = 0)
a. Lab (t=1 / 18:00): Routine laboratory screening (calcium, phosphate,
albumin, vitamin D), including: PTH for the study
3. Day after surgery (Day = +1)
a. Lab (t=2 / 08:00): Routine laboratory screening (calcium, phosphate,
albumin), including: PTH for the study
4. 1-2 weeks after surgery
a. Lab (t=3): Routine laboratory screening (calcium, phosphate, albumin),
including: PTH for the study
5. 1 year after surgery
a. Lab (t=4): Routine laboratory screening (calcium, phosphate, albumin),
including: PTH for the study
Interpretation of laboratory findings and calcium supplementation are based on
the existing protocol (Attachment 1) which is not changed for the purpose of
the study.
Study burden and risks
not applicable.
s'-gravendijkwal 213
Rotterdam 3015 CE
NL
s'-gravendijkwal 213
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients scheduled for a total thyroidectomy (or subtotal if the istmus is to remain in situ) or completion thyroidectomy are to be included in this study.
Exclusion criteria
Patients undergoing concomitant lymph node dissection may also be included in the study.
o Age < 18
o Unable to provide informed consent
o Pre-operative disorders in calcium homeostasis: hypo/hypercalcaemia with/without calcium supplementation
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 | NL43050.078.12 |