The aim of this multi-centre study is to confirm the efficiency and safety of a new algorithm for calcium management after total thyroidectomy, primarily based on hypocalcemic symptoms.
ID
Source
Brief title
Condition
- Parathyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the difference in the percentage of patients
treated with calcium (and active vitamin D3-metabolite) supplements before and
after implementation of the new algorithm.
Secondary outcome
1. Number of readmissions for intravenous calcium supplementation
2. Number of calcium related contacts with the outpatient department
3. The incidence of hypocalcemia: both transient and permanent
4. Risk factors for hypocalcemia (patient or surgery related)
5. Incidence of hypocalcemic symptoms emerging after discharge
6. Complications related to hypocalcemia
7. Duration of admission
8. Number of patients requiring intravenous calcium supplementation
9. Relation between EKG abnormalities and hypocalcemia
Background summary
Hypocalcemia can occur in up to 27% of patients after total thyroidectomy
mainly due to edema, ischemia or removal of parathyroid glands (PTGs).
Treatment of hypocalcemia after total thyroidectomy is currently based on serum
calcium and parathyroid hormone (PTH) levels. Unfortunately, there is no
evidence-based guideline available. Recently a single centre study suggested
patients can be treated safely and efficiently based solely on the occurrence
of hypocalcemic symptoms, irrespective of serum calcium levels. Based on this
observation, a new treatment algorithm for hypocalcemia was developed for the
Dutch clinical setting. This treatment algorithm is expected to optimise
testing and treatment allocation and to reduce unnecessary calcium treatment.
This will ultimately alleviate the burden for patients and results in lower
health care costs.
Study objective
The aim of this multi-centre study is to confirm the efficiency and safety of a
new algorithm for calcium management after total thyroidectomy, primarily based
on hypocalcemic symptoms.
Study design
A prospective multi-centre implementation study of the new algorithm will be
performed. After total thyroidectomy, all patients included in the study, will
be treated according to this algorithm. Patients on calcium (and vitamin D
metabolite) supplementation will receive instructions to phase out medication
at home. The study population will be compared to a retrospective cohort of
post-thyroidectomy patients operated before introduction of the new algorithm.
Intervention
New treatment algorithm
Study burden and risks
Patients will be asked to fill in hypocalcemic symptoms in a diary. The number
of venepunctures during peri-operative care will not exceed current standard
care, although extra tubes will be withdrawn during these venepunctures.
Additionally, one extra EKG will be performed. The new treatment algorithm is
primarily based on hypocalcemic symptoms. As noted earlier, a recent study
treating only symptomatic patients, did not demonstrate serious complications
associated with hypocalcemia. In our study an extra safety measurement is
included: all patients will receive calcium supplementation irrespective of
symptoms if the serum calcium level drops below 1.85 mmol/L. Furthermore
patients will be carefully informed about hypocalcemic symptoms and will
receive instructions what to do if these symptoms develop at home.
The number of patients treated with calcium supplements is expected to decrease
due to the new algorithm. As a consequence the burden for patients will be
alleviated in terms of the amount of visits to the outpatient clinic and
discomfort associated with taking calcium supplements. Less patients will risk
interaction of calcium supplementation with other medication, contributing to
safe and efficient patient care.
Maasstadweg 21 Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21 Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
1. Indication for total thyroidectomy or completion thyroidectomy
2. Patient age 18 years or older at the time of inclusion
Exclusion criteria
1. Pre-operative abnormal adjusted serum calcium level (reference range 2.20 -2.55 mmol/L)
2. Hyperparathyroidism
3. Planned parathyroidectomy
4. History of epileptic seizures
5. Pregnancy
6. Non dutch speaking
7. Not able to give informed consent
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 | NL59859.101.16 |