Quality of Life After Thyroidectomy (ThyrQol) (ThyrQol)

August 9, 2017 updated by: Nantes University Hospital

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

890

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers University Hospital
      • La Roche sur Yon, France, 85925
        • CHD La Roche sur Yon
      • Limoges, France, 87042
        • Limoges University Hospital
      • Lyon, France, 69000
        • Lyon University Hospital
      • Nancy, France, 54511
        • Nancy University Hospital
      • Nantes, France, 44093
        • Nantes University Hospital
      • Paris, France, 75013
        • La Pitié-Salpétrière - AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A prospective, non randomized, open, multicenter trial to evaluate quality of life (SF 36) and voice function (VHI questionnaire) before and after totalthyroidectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Evaluation at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Evaluation at 2 and 6 months
Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)
Time Frame: Evaluation at 2 and 6 months
Evaluation at 2 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Eric MIRALLIE, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC11_0194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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