NCT02167529CompletedNot Applicable
A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.
Nantes University Hospital7 sites in 1 country890 target enrollmentStarted: March 6, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 890
- Locations
- 7
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Time Frame: Evaluation at 6 months
Secondary Outcomes
- 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)
Investigators
Study Sites (7)
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