Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07491601

PRESS-PAR: Early Detection and Prevention of Symptomatic Post-Surgical Hypoparathyroidism After Thyroid Surgery

Led by Nicolas Schlegel · Updated on 2026-03-24

336

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

Nicolas Schlegel

Lead Sponsor

U

University of Wuerzburg

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates whether measuring parathyroid hormone earlier after thyroid surgery can reduce the number of patients who develop symptoms of hypoparathyroidism. The goal is to create a clear approach to manage this condition, improve patients' quality of life, reduce distress, and potentially shorten hospital stays. The study focuses on patients undergoing thyroidectomy or bilateral thyroid resection for any reason. Participants are randomly assigned to one of two groups. In the control group, parathyroid hormone and calcium levels are measured on the first day after surgery as part of routine care. In the intervention group, these measurements occur within the first 3 hours after surgery, plus again on the first postoperative day. Both groups receive vitamin D and calcium supplements if hormone levels fall below normal. The study includes baseline and postoperative quality-of-life assessments using standardized questionnaires and symptom scales. Throughout the study, patients undergo clinical visits on the day of surgery and the following two days, with an additional visit and lab testing between days 8 and 10 after discharge if needed. Six months after surgery, participants are contacted by phone to evaluate long-term symptoms, quality of life, and ongoing supplementation needs. Those with persistent hypoparathyroidism after six months are referred for specialized endocrine care outside the study. Researchers monitor hormone and calcium levels in certified laboratories and evaluate outcomes such as symptom scores, hospital stay length, therapy initiation, quality of life, and readmissions due to hypocalcemia.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing thyroidectomy or bilateral thyroid resection for any indication
  • Able to provide written informed consent after receiving detailed study information
Not Eligible

You will not qualify if you...

  • Age 18 years or younger
  • Existing parathyroid disease such as primary or secondary hyperparathyroidism or any cause of hypoparathyroidism
  • Previous surgery in the neck region
  • Pregnancy or breastfeeding
  • Unable to attend study visits
  • Participation in another study that interferes with the endpoints
  • Missing or inadequate patient information

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Hospital stay up to 14 days, on average 2 days

Participants undergo thyroid surgery and are randomly assigned to early or standard postoperative hormone and calcium measurement. Vitamin D and calcium supplementation is started if parathyroid hormone levels fall below normal.

Clinical visits on days 0, 1, and 2 post-surgery; additional visit on days 8-10 for some participants

Follow-up

Duration - 6 months

Participants are contacted by telephone after 6 months to assess symptoms, quality of life, and ongoing supplementation needs.

1 telephone follow-up

Trial Site Locations

Total: 1 location

1

Dept. Surgery I; University Hospital Wuerzburg

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

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Research Team

N

Nicolas Schlegel, Prof. Dr. (MD)

N

Nicole Kirschbauer, Study Nurse

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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