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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

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.

Condition or disease Intervention/treatment
Hypocalcemia, Postoperative Parathormone Diagnostic Test: parathormone level

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control-normocalcemia group Diagnostic Test: parathormone level
From the patients, blood will be taken preoperatively and postoperatively.
Other Name: calcium level

hypocalcemia group Diagnostic Test: parathormone level
From the patients, blood will be taken preoperatively and postoperatively.
Other Name: calcium level




Primary Outcome Measures :
  1. postoperative parathormone level [ Time Frame: postoperative 2. hour ]

Biospecimen Retention:   Samples Without DNA
blood samples for biochemical evaluation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717116


Contacts
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Contact: selen soylu +905375653811 selen_soylu@yahoo.com

Locations
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Turkey
Istanbul University Recruiting
Istanbul, Turkey, 34158
Contact: selen soylu, MD    5375653811      
Sponsors and Collaborators
Istanbul University
Additional Information:

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Responsible Party: Selen Soylu, MD, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT03717116    
Other Study ID Numbers: 83045809-604.01.02, A-01
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selen Soylu, MD, Istanbul University:
hypocalcemia, parathormone, bone density
Additional relevant MeSH terms:
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Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs