Study on the Effects of Hypoparathyroidism on Post-thyroidectomy Health-related Quality of Life (QoL-hPTP)

NCT04604808 | Completed

• 1 other identifier: QoL-hPTP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Our study will evaluate the health related quality of life (HRQoL) after a thyroidectomy and the relevance of postoperative hypoparathyroidism. The patients submitted to a total thyroidectomy will be evaluated with three questionaries (SF-36, Hospital HADS and a specifically designed Likert-type questionary about the intensity of hypoparathyroidism symptoms). The first evaluation will be before the surgery, and the other two will be completed a week and a month after the procedure.

Conditions

Hypoparathyroidism Postprocedural

Keywords

Health-related Quality of Life; Thyroidectomy; Postoperative hypoparathyroidism

Outcome Measures

Primary Outcomes (3)

• Change in SF-36 score

  36-Item Short Form Health Survey questionnaire: 0 to 100 points, been a lower score a worse outcome

  Preoperative, one week and one month after surgery

• Change in HADS score

  Hospital Anxiety and Depression Scale: 0 to 42 points, been a higher score a worse outcome

  Preoperative, one week and one month after surgery

• Changes Questionary of hypocalcemia symptoms

  Specifical designed Liker-type questionary: Likert scale based score, from 1 to 10 points, been a higher score a worse outcome

  Preoperative, one week and one month after surgery

Study Arms (2)

Non hypocalcemic group

Patients that don't develop post-thyroidectomy hypocalcemia

Hypocalcemic group

Patients that develop post-thyroidectomy hypocalcemia

Eligibility Criteria

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

Study Population

Patients submitted to total thyroidectomy according to clinical practice.

You may qualify if:

• Patients submitted to total thyroidectomy
• Patients older than 18 yo
• Patients who accept participating in the study.
• Patients who, before the surgery, have done a complete laboratory test.
• Patients followed for at least one month after surgery.

You may not qualify if:

• \- Patients submitted to a subtotal or completion thyroidectomy

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (1)

Hospital Universitario de La princesa

Madrid, 28006, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrine Surgeon Consultant

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 27, 2020
• Study Start: October 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: November 30, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

ES (1)