Quality of Life After Thyroidectomy (ThyrQol)

Total Thyroidectomy Clinical Trial

— ThyrQol  

Official title:

A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167529
• Other study ID #: RC11_0194
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: August 9, 2017
• Start date: March 6, 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: August 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult over 18 years

• Notice to total thyroidectomy

• Thyroidectomy under cervicotomy or videoscopy

• Existence of a written informed consent of the patient

• Affiliation to a social security

• Possible follow-up for 6 months

Exclusion Criteria:

• Impossibility for the patient to complete the forms

• Impossibility to follow the patient patient with serious disease which impact the quality of life

• Medullary thyroid cancers

• Preoperative examination of vocal cords (if performed) finding a violation of the vocal cords

• Lack of monitoring possible during the 6 months after surgery

• Pregnant women or during lactation

• Minors and adults under guardianship

Related Conditions & MeSH terms

• Total Thyroidectomy

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	CHD La Roche sur Yon	La Roche sur Yon
France	Limoges University Hospital	Limoges
France	Lyon University Hospital	Lyon
France	Nancy University Hospital	Nancy
France	Nantes University Hospital	Nantes
France	La Pitié-Salpétrière - AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the differences in terms of impact on quality of life among patients without sequelae 6 months after thyroidectomy (laryngeal paralysis or hypoparathyroidism) and patients with hypoparathyroidism. (SF36 v1,3, self-administered questionnaire)		Evaluation at 6 months
Secondary	Evaluation of the impact of post thyroidectomy laryngeal paralysis on the quality of life (SF36 v1,3, self-administered questionnaire)		Evaluation at 2 and 6 months
Secondary	Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)		Evaluation at 2 and 6 months