Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endocrine Procedural Complications, Thyroid, Parathyroid; Deficiency, Laryngeal Injury. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
Overview
The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.
Detailed description
Intraoperative PTH values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy.
Postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively.
Other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.
Primary outcome measures
- intraoperative parathormone values [Time frame: intraoperative]
Secondary outcome measures (8)
- postoperative hypocalcemia [Time frame: within 1 week after thyroidectomy]
- postoperative hypoparathyroidism [Time frame: within 1 week after thyroidectomy]
- permanent postoperative hypocalcemia [Time frame: at one year after thyroidectomy]
- permanent postoperative hypoparathyroidism [Time frame: at one year after thyroidectomy]
- laryngeal nerve palsy [Time frame: during thyroidectomy]
- laryngeal nerve palsy [Time frame: within 1 week after thyroidectomy]
- laryngeal nerve palsy [Time frame: at one year after thyroidectomy]
- Postoperative complications other than outcomes from 1 to 8 [Time frame: at one year after thyroidectomy]
Eligibility criteria
Inclusion criteria
- patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Exclusion criteria
- refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT03309384 · PARACAL · R2016-25