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

NCT07491601 | Recruiting

• 1 other identifier: Version II /05- 2024
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgical Hypoparathyroidism; Hypoparathyroidism Post-surgical; Postoperative Hypoparathyroidism

Keywords

Thyroid surgery; Perioperative medicine; Postoperative Hypoparathyroidism; Calcium supplementation; Active Vitamin D supplementation; Quality of life after surgery; Post-surgical Hypoparathyroidism

Outcome Measures

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.

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

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard of Care

SHAM COMPARATOR

Measurement of parathormone levels and calcium on postoperative day 1 (beginning at day 1 after surgery)

Drug: Active vitamin D; Drug: Calcium

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

Drug: Active vitamin D; Drug: Calcium

Interventions

Active vitamin D DRUG

Application if parathyroid hormone level falls below normal

Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery)); Standard of Care

Calcium DRUG

Administered if parathyroid hormone level falls below normal

Early postoperative sampling of parathyroid hormone and Calcium (within 1-3 hours after surgery)); Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolas Schlegel: lead
• University of Wuerzburg: collaborator

Study Sites (1)

Dept. Surgery I; University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Nicolas Schlegel, Prof. Dr. (MD)

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Nicolas Schlegel

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: March 24, 2026
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)