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Completed

NCT Number: NCT02167529

Quality of Life After Thyroidectomy (ThyrQol)

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.

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Key information

Conditions

Total Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    Time frame: Evaluation at 6 months

Secondary outcomes

  1. Evaluation of the impact of post thyroidectomy laryngeal paralysis on the quality of life (SF36 v1,3, self-administered questionnaire)

    Time frame: Evaluation at 2 and 6 months

  2. Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)

    Time frame: Evaluation at 2 and 6 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ThyrQol

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 19, 2014
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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