Quality of Life After Thyroidectomy (ThyrQol)

Completed

• Conditions: Total Thyroidectomy

• Registration Number: NCT02167529
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Primary Completion: 2016-12-31
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)	Evaluation at 2 and 6 months

Trial Locations

Locations (7)

Limoges University Hospital; 🇫🇷 Limoges, France

Angers University Hospital; 🇫🇷 Angers, France

CHD La Roche sur Yon; 🇫🇷 La Roche sur Yon, France

Nancy University Hospital; 🇫🇷 Nancy, France

Lyon University Hospital; 🇫🇷 Lyon, France

Nantes University Hospital; 🇫🇷 Nantes, France

La Pitié-Salpétrière - AP-HP; 🇫🇷 Paris, France