Total ThyroidectomyThyrQolNCT02167529
Quality of Life After Thyroidectomy (ThyrQol)
An observational study of Total Thyroidectomy, run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Thyroidectomy
- How many people
- 890 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Mar 2014to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Angers University Hospital
Angers, 49933
CHD La Roche sur Yon
La Roche-sur-Yon, 85925
Limoges University Hospital
Limoges, 87042
Lyon University Hospital
Lyon, 69000
Nancy University Hospital
Nancy, 54511
Nantes University Hospital
Nantes, 44093
La Pitié-Salpétrière - AP-HP
Paris, 75013
About this study
Official title: 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.
- Conditions
- Total Thyroidectomy
- Keywords
- Quality of life-Thyroidectomy-Morbidity
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Evaluation at 2 and 6 months
Evaluation of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)
Measured: Evaluation at 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start6 Mar 2014
- Primary completion31 Dec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Mirallié, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167529
- Sponsor's protocol ID
- RC11_0194
- Acronym
- ThyrQol
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.
- ClinicalTrials.gov ID
- NCT02167529
- Acronym / sponsor ID
- ThyrQol / RC11_0194
- Conditions
- Total Thyroidectomy
- Keywords
- Quality of life-Thyroidectomy-Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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 of difficulties voice after total thyroidectomy (with or without laryngeal complication) (VIH questionnaire)
Time frame: Evaluation at 2 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
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Role of Total Thyroidectomy in Relieving Local Symptoms in Hashimoto's Thyroiditis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Mirallié, Pr principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Thyroidectomy, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.