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

NCT01027091 | Unknown

• 1 other identifier: 7/06-11-09
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia After Total Thyroidectomy

Keywords

hypocalcemia; total thyroidectomy

Outcome Measures

Primary Outcomes (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.

  6hr, 12hr, 24hr, 48hr postopreratively

Secondary Outcomes (4)

• The correlation between development of hypocalcaemia in patients after total thyroidectomy with the following factors: · Gender, · Age,

• The correlation between development of hypocalcaemia and the Intraoperative recognition of parathyroid glands and possible autotransplantation of parathyroid glands,

• The correlation between development of hypocalcaemia in patients after total thyroidectomy with the Underlying thyroid pathology based on the histological-pathological report:

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• patients treated with substitutes calcium and vitamin D.

Sponsors & Collaborators

• G. Hatzikosta General Hospital: lead

Study Sites (1)

G.Hatzikosta General Hospital

Ioannina, Ioannina, 45221, Greece

RECRUITING

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Evangelos K Tsimoyiannis, DR, MD, FACS, FABI,

  G. Hatzikosta General Hospital

  STUDY DIRECTOR

Central Study Contacts

George A. Economou, M.D

CONTACT

0030265103294; georgeconomou@gmail.com

Evangelos K Tsimoyiannis, M.D, DR., FACS, FABI

CONTACT

00302651080513; etsimogi@ath.forthnet.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 7, 2009

Record last verified: 2009-11

Locations

GR (1)