PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicolas Schlegel

About this trial

This study aims to investigate whether an earlier measurement of parathyroid hormone can reduce the number of patients who develop symptomatic hypoparathyroidism. This will provide evidence for a clear algorithm to address this issue after thyroid surgery. It will lead to an improvement in quality of life and a reduction in the distress experienced by affected patients. In addition, it is conceivable that patients' hospital stay could be shortened.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Thyroidectomy or bilateral thyroid resection of any indication

Written informed consent obtained after detailed patient information and provision of an information sheet

Disqualifiers

Age ≤ 18 years

Concomitant parathyroid disease (primary or secondary hyperparathyroidism, pre-existing hypoparathyroidism of any cause)

Previous surgery in the neck region

Pregnancy or breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active vitamin D

    Drug

    Application if parathyroid hormone level falls below normal

  • Calcium

    Drug

    Administered if parathyroid hormone level falls below normal

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: Standard of CareSham comparator 2 interventions
Group B: Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery))Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Symptomatic hypoparathyroidism (symptom score) with hypocalcemia

Symptomatic hypoparathyroidism is defined as the presence of one or more symptoms reported in the questionnaire.

Time frame
within hospital stay (0-48hours after bilateral thyroid surgery)

Secondary outcomes

1

Length of Hospital stay

Duration of hospital stay

Time frame
up to 14 days after surgery, on average 2 days
2

Initation of substitution therapy with active vitamin D and calcium

Duration of supplementation based on symtptoms and biochemical restoration of PTH levels

Time frame
up to 6 months after surgery
3

Quality of life with changes in psychological burden

Measurement of Quality of Life using Short Form (36) Healthy Survey (SF36), State-Trait Anxiety Inventory- German version (STAI-G) and Hypoparathyroidism Patient Questionnaire 28 (HPQ28)

Time frame
up to 1 day before surgery or earlier and after 6 months after surgery
4

Patient readmission due to hypocalcemia with or without symptoms

Patients with problems after discharge who require readmission

Time frame
up to 6 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicolas Schlegel

Lead sponsor

University of Wuerzburg

Sponsor institution

University of Wuerzburg

Collaborator