PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 336
- Locations
- 1
- Primary Endpoint
- Symptomatic hypoparathyroidism (symptom score) with hypocalcemia
Study Overview
Brief Summary
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.
Detailed Description
Information and Recruitment First, patients who meet the inclusion criteria and do not meet any exclusion criteria will be identified in our surgical-endocrine outpatient clinic. All concomitant medications, particularly any pre-existing vitamin D intake, will be documented. As part of the routine blood sampling, parathyroid hormone, calcium, and vitamin D are determined according to the guidelines in order to detect any pre-existing parathyroid disorders (exclusion criteria). After informing the patient about the indication, necessity, and risks of the planned procedure, an additional explanation is given regarding the possibility of participating in the study.
Both written and oral information about the study will be provided to the patient.
Study Timeline The planned recruitment period is 3 years, followed by a 6-month follow-up. Study Visits After patients are enrolled in the study, baseline characteristics are collected, as well as quality-of-life data using standardized questionnaires (SF-36, STAI-G) and the Health Patient Questionnaire (HPQ28), along with a modified version of the "Hypoparathyroidism Patient Experience Scale - Symptom (HPES)." This questionnaire is included in the appendices and has so far been validated for chronic hypoparathyroidism. Validation for the acute setting is currently being carried out through targeted surveys of our own patient cohort during routine perioperative visits.
Postoperative clinical visits take place on days 0, 1, and 2 in accordance with current clinical standards. In the intervention group, parathyroid hormone is measured directly postoperatively within the first 3 hours after surgery. In the control group, this measurement is performed on the first postoperative day (within 24 hours after surgery) during routine blood sampling. This measurement is also carried out at the same time point-on the first postoperative day-in the intervention group. In both groups, vitamin D and calcium supplementation is initiated if the parathyroid hormone level falls below the normal range. On postoperative days 1 and 2, both groups complete the HPES, HPQ28, and STAI-G questionnaires.
As part of the study, an additional clinical visit and laboratory testing is performed after discharge on days 8-10. This additional visit is normally conducted only in patients who showed abnormalities during their hospital stay, such as low calcium or parathyroid hormone levels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Inability to attend study visits
- •Participation in another study that interferes with the endpoints
- •Missing or inadequate patient information
Arms & Interventions
Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery))
Measurement of parahthyroid hormone and calcium within 1-3 hours post surgery
Intervention: Active vitamin D (Drug)
Standard of Care
Measurement of parathormone levels and calcium on postoperative day 1 (beginning at day 1 after surgery)
Intervention: Calcium (Drug)
Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery))
Measurement of parahthyroid hormone and calcium within 1-3 hours post surgery
Intervention: Calcium (Drug)
Standard of Care
Measurement of parathormone levels and calcium on postoperative day 1 (beginning at day 1 after surgery)
Intervention: Active vitamin D (Drug)
Outcomes
Primary Outcomes
Symptomatic hypoparathyroidism (symptom score) with hypocalcemia
Time Frame: within hospital stay (0-48hours after bilateral thyroid surgery)
Symptomatic hypoparathyroidism is defined as the presence of one or more symptoms reported in the questionnaire.
Secondary Outcomes
- Length of Hospital stay(up to 14 days after surgery, on average 2 days)
- Initation of substitution therapy with active vitamin D and calcium(up to 6 months after surgery)
- Quality of life with changes in psychological burden(up to 1 day before surgery or earlier and after 6 months after surgery)
- Patient readmission due to hypocalcemia with or without symptoms(up to 6 months after surgery)
Investigators
Nicolas Schlegel
Prof. Dr. med. Nicolas Schlegel
University of Wuerzburg