Trial record 4 of 13 for:    Open Studies | "Hypocalcemia"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by G. Hatzikosta General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT01027091
First received: December 4, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Hypocalcemia After Total Thyroidectomy

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by G. Hatzikosta General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The correlation between development of hypocalcaemia in patients after total thyroidectomy with the following factors: · Gender, · Age, [ Designated as safety issue: No ]
  • The correlation between development of hypocalcaemia and the Intraoperative recognition of parathyroid glands and possible autotransplantation of parathyroid glands, [ Designated as safety issue: No ]
  • The correlation between development of hypocalcaemia in patients after total thyroidectomy with the Underlying thyroid pathology based on the histological-pathological report: [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 4, 2009
Last Updated: December 4, 2009
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014