Quality of Life After Thyroidectomy (ThyrQol)
ThyrQol
A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.
1 other identifier
observational
890
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 11, 2017
August 1, 2017
2.8 years
June 17, 2014
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Eligibility Criteria
A prospective, non randomized, open, multicenter trial to evaluate quality of life (SF 36) and voice function (VHI questionnaire) before and after totalthyroidectomy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Angers University Hospital
Angers, 49933, France
CHD La Roche sur Yon
La Roche-sur-Yon, 85925, France
Limoges University Hospital
Limoges, 87042, France
Lyon University Hospital
Lyon, 69000, France
Nancy University Hospital
Nancy, 54511, France
Nantes University Hospital
Nantes, 44093, France
La Pitié-Salpétrière - AP-HP
Paris, 75013, France
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Mirallié, Pr
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
March 6, 2014
Primary Completion
December 31, 2016
Study Completion
August 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08