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| Name | Class |
|---|---|
| University of Wuerzburg | OTHER |
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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.
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.
Finally, after 6 months, patients are contacted again by telephone to assess the secondary endpoints, including a renewed evaluation of quality of life. The telephone follow-up also determines whether patients are still experiencing any symptoms at that time and whether continued vitamin D and calcium supplementation is necessary. For patients who did not develop postoperative hypoparathyroidism, the goal is to exclude the possibility that delayed symptoms have occurred (even though this is rare). Furthermore, it should be clarified whether early intervention to prevent symptomatic hypoparathyroidism leads to better long-term quality of life.
Patients in whom the condition persists long-term-i.e., after 6 months-will, as in current clinical routine, be referred to endocrinology for ongoing therapy and monitoring. There is already close collaboration with Prof. Dr. Stefanie Hahner and Prof. Dr. Carmina Fuß in endocrinology. This follow-up is no longer part of the study.
Together with the collaborating partners from endocrinology measurements of parathyroid hormone and calcium levels will be performed according to the UKW standard in the central laboratory and in the endocrinology laboratory. The standards and measurement methods in both laboratories are well established. No technical changes are expected in the coming years, as new devices for parathyroid hormone testing were recently acquired by the endocrinology department.
Randomization Randomization is carried out during or shortly after the surgical procedure by staff of the Surgical Study Center Würzburg. Randomization is performed using the platform "Randomizer.at." Registration takes place after approval by the ethics committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Sham Comparator | Measurement of parathormone levels and calcium on postoperative day 1 (beginning at day 1 after surgery) |
|
| Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery)) | Experimental | Measurement of parahthyroid hormone and calcium within 1-3 hours post surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active vitamin D | Drug | Application if parathyroid hormone level falls below normal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic hypoparathyroidism (symptom score) with hypocalcemia | Symptomatic hypoparathyroidism is defined as the presence of one or more symptoms reported in the questionnaire. | within hospital stay (0-48hours after bilateral thyroid surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital stay | Duration of hospital stay | up to 14 days after surgery, on average 2 days |
| Initation of substitution therapy with active vitamin D and calcium | Duration of supplementation based on symtptoms and biochemical restoration of PTH levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Schlegel, Prof. Dr. (MD) | Contact | +49 931 201 38217 | SCHLEGEL_N@ukw.de | |
| Nicole Kirschbauer, Study Nurse | Contact | +49 931 201 31173 | kirschbauer_n@ukw.de |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Schlegel, Prof. Dr. (MD) | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Surgery I; University Hospital Wuerzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
Individual participant data will not be shared due to data protection regulations and lack of participant consent for data sharing
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This is a multicenter, two-arm, randomized interventional study. It is important to emphasize that patients receive the same diagnostics and treatment as currently standard practice. The only difference is that these are either performed earlier, depending on allocation to one of the study arms, or carried out at the usual time according to current practice.
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| Calcium | Drug | Administered if parathyroid hormone level falls below normal |
|
| up to 6 months after surgery |
| 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) | up to 1 day before surgery or earlier and after 6 months after surgery |
| Patient readmission due to hypocalcemia with or without symptoms | Patients with problems after discharge who require readmission | up to 6 months after surgery |
| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
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