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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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.

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.


Detailed Summary:

INTRODUCTION:

In recent years there has been a global trend towards more radical and aggressive approach to thyroid surgery (total or subtotal thyroidectomy against semithyreoeidectomy), almost regardless of the pathological cause, even for benign diseases. There is also developed, a serious skepticism as complications of total or subtotal thyroidectomy is neither rare nor insignificant. In particular, complications of thyroidectomy is the laryngeal nerve paresis (0.2% bilateral, unilateral 3,7-3,9%, 2% transient, lasting 1%), bleeding (1-2%), infection of the wound (0, 3-1,6%) and hypocalcaemia (permanent hypocalcaemia in over 6 months follow up 1,7-4,4%, while transient, manageable with vit D and calcium substitution 8,3-9,9%). The post total thyroidectomy hypocalcaemia is not only more frequent but also has the most delayed onset after surgery (up to several 24hours later) in relation to bleeding and paresis of the laryngeal nerve, which is immediate postoperative complications. This is the main cause of prolonged hospitalization and monitoring of patients postoperatively which is linked to increased risk of bacterial infections and increased cost.9, 10 Great effort has been made in the last 15 years to reduce the length hospital stay of patients in order to perform the total thyroidectomy as a one day surgery.6, 11 In this way great importance is the prediction of those patients are more likely to experience post-operative hypocalcaemia. The appearance of postoperative hypocalcaemia associated with specific diseases such as thyroid disease Graves, the thyreotoxicosis and thyroid cancer 7.8, and the surgical technique (the extent of excision, the type of thyroid artery ligation, the number of parathyroid recognized intraoperative but also those autotransplanted) 12. Moreover, beyond these factors, great importance is given to methods of monitoring patients to find reli
Sponsor: G. Hatzikosta General Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: G. Hatzikosta General Hospital

Dates:
Date Received: December 4, 2009
Date Started: November 2008
Date Completion: January 2011
Last Updated: December 4, 2009
Last Verified: November 2009