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The Study of a Safe and Cost-effective Method to Identify Patients at Low Risk of Significant Hypocalcemia After Total Thyroidectomy.

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ClinicalTrials.gov Identifier: NCT01027091
Recruitment Status : Unknown
Verified November 2009 by G. Hatzikosta General Hospital.
Recruitment status was:  Recruiting
First Posted : December 7, 2009
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

Hypocalcemia is the complication, after total thyroidectomy, that usually determines the length of hospital stay.Serum calcium levels is a quick and cost-effective practice to recognise hypocalcemia in the postoperative follow up.

OBJECTIVE: The objective of this perspective study is to determine if consecutive postoperative serum calcium levels early after total thyroidectomy can be used to identify patients who are unlikely to develop significant hypocalcemia and can be safely discharged within 24 to 48 hours postoperative.


Condition or disease
Hypocalcemia After Total Thyroidectomy

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of a Safe and Cost-effective Method to Identify Patients at Low Risk for the Development of Significant Hypocalcemia After Total Thyroidectomy.
Study Start Date : November 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : January 2011
Groups and Cohorts

Group/Cohort
patients with positive slope
patients with positive slope in the levels of free serum calcium levels between 6th and 12th postoperative hour
patients with negative or no slope
patients with negative or no slope in the levels of free serum calcium levels between 6th and 12th postoperative hour.


Outcome Measures

Primary Outcome Measures :
  1. Correlation of the variability of the levels of free serum calcium (Ca + +), between two measurements on 6 and 12 hours postoperatively, the incidence of hypocalcaemia in patients undergoing total thyroidectomy for any reason. [ Time Frame: 6hr, 12hr, 24hr, 48hr postopreratively ]

Secondary Outcome Measures :
  1. The correlation between development of hypocalcaemia in patients after total thyroidectomy with the following factors: · Gender, · Age,
  2. The correlation between development of hypocalcaemia and the Intraoperative recognition of parathyroid glands and possible autotransplantation of parathyroid glands,
  3. The correlation between development of hypocalcaemia in patients after total thyroidectomy with the Underlying thyroid pathology based on the histological-pathological report:
  4. The correlation between development of hypocalcaemia in patients after total thyroidectomy with the following factors: Use of Ligasure use of Ultracision, Use of hemostatic,Volume of blood loss, Volume and weight of specimen

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with any thyroid pathology undergoing total thyroidectomy regardless of gender, age and medication
Criteria

Inclusion Criteria:

  • patients with any thyroid pathology undergoing total thyroidectomy regardless of gender, age and medication

Exclusion Criteria:

  • patients treated with substitutes calcium and vitamin D.
Contacts and Locations

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): NCT01027091


Contacts
Contact: George A. Economou, M.D 0030265103294 georgeconomou@gmail.com
Contact: Evangelos K Tsimoyiannis, M.D, DR., FACS, FABI 00302651080513 etsimogi@ath.forthnet.gr

Locations
Greece
G.Hatzikosta General Hospital Recruiting
Ioannina, Greece, 45221
Contact: Evangelos K Tsimoyiannis, DR, FACS, FABI    00302651080513    etsimogi@ath.forthnet.gr   
Sponsors and Collaborators
G. Hatzikosta General Hospital
Investigators
Study Director: Evangelos K Tsimoyiannis, DR, MD, FACS, FABI, G. Hatzikosta General Hospital
More Information

Responsible Party: George A. Economou resident of G.Hatzikosta G.H Surgery Department, G.Hatzikosta General Hospital
ClinicalTrials.gov Identifier: NCT01027091     History of Changes
Other Study ID Numbers: 7/06-11-09
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: November 2009

Keywords provided by G. Hatzikosta General Hospital:
hypocalcemia
total thyroidectomy

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance