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
Recruitment status was Recruiting
Sponsor:
G. Hatzikosta General Hospital
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
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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
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 June 18, 2013