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Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717116
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Selen Soylu, MD, Istanbul University

Tracking Information
First Submitted Date October 22, 2018
First Posted Date October 24, 2018
Last Update Posted Date October 24, 2018
Actual Study Start Date September 1, 2017
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2018)
postoperative parathormone level [ Time Frame: postoperative 2. hour ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
Official Title Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
Brief Summary Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples Without DNA
Description:
blood samples for biochemical evaluation
Sampling Method Non-Probability Sample
Study Population all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
Condition Hypocalcemia, Postoperative Parathormone
Intervention Diagnostic Test: parathormone level
From the patients, blood will be taken preoperatively and postoperatively.
Other Name: calcium level
Study Groups/Cohorts
  • control-normocalcemia group
    Intervention: Diagnostic Test: parathormone level
  • hypocalcemia group
    Intervention: Diagnostic Test: parathormone level
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 22, 2018)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy

Exclusion Criteria:

  • pregnant women
  • patients with thyroid cancer or previous neck dissection
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: selen soylu +905375653811 selen_soylu@yahoo.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03717116
Other Study ID Numbers 83045809-604.01.02, A-01
Has Data Monitoring Committee No
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
Plan to Share IPD: Undecided
Responsible Party Selen Soylu, MD, Istanbul University
Study Sponsor Istanbul University
Collaborators Not Provided
Investigators Not Provided
PRS Account Istanbul University
Verification Date October 2018