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Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy (PARACAL)

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ClinicalTrials.gov Identifier: NCT03309384
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Laurent BRUNAUD, Central Hospital, Nancy, France

Tracking Information
First Submitted Date September 6, 2017
First Posted Date October 13, 2017
Last Update Posted Date January 12, 2022
Study Start Date March 20, 2016
Estimated Primary Completion Date March 20, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2017)		 intraoperative parathormone values [ Time Frame: intraoperative ]
parathormone in pg/mL
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 12, 2017)
  • postoperative hypocalcemia [ Time Frame: within 1 week after thyroidectomy ]
    calcium in mg/L
  • postoperative hypoparathyroidism [ Time Frame: within 1 week after thyroidectomy ]
    parathormone in pg/mL
  • permanent postoperative hypocalcemia [ Time Frame: at one year after thyroidectomy ]
    calcium in mg/L
  • permanent postoperative hypoparathyroidism [ Time Frame: at one year after thyroidectomy ]
    parathormone in pg/mL
  • laryngeal nerve palsy [ Time Frame: during thyroidectomy ]
    continuous intraoperative neuromonitoring (> 50% baseline values yes/no)
  • laryngeal nerve palsy [ Time Frame: within 1 week after thyroidectomy ]
    laryngoscopy (normal / palsy)
  • laryngeal nerve palsy [ Time Frame: at one year after thyroidectomy ]
    laryngoscopy (normal / palsy)
  • Postoperative complications other than outcomes from 1 to 8 [ Time Frame: at one year after thyroidectomy ]
    Postoperative morbidity classification (using a Clavien-Dindo classification) postoperatively
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy
Official Title Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
Brief Summary 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Condition
  • Endocrine Procedural Complications
  • Thyroid
  • Parathyroid; Deficiency
  • Laryngeal Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 12, 2017)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 20, 2026
Estimated Primary Completion Date March 20, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients scheduled for total thyroidectomy in university of Nancy (University Hospital)

Exclusion Criteria:

  • refusal to participate
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Brunaud l.brunaud@chru-nancy.fr
Contact: Jacquel s.jacquel@chru-nancy.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03309384
Other Study ID Numbers PARACAL
R2016-25 ( Registry Identifier: CNIL )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Laurent BRUNAUD, Central Hospital, Nancy, France
Original Responsible Party Same as current
Current Study Sponsor Central Hospital, Nancy, France
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Brunaud CHU Nancy
PRS Account Central Hospital, Nancy, France
Verification Date January 2022