Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01027091 |
| Other study ID # |
7/06-11-09 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
December 4, 2009 |
| Last updated |
December 4, 2009 |
| Start date |
November 2008 |
| Est. completion date |
January 2011 |
Study information
| Verified date |
November 2009 |
| Source |
G. Hatzikosta General Hospital |
| Contact |
George A. Economou, M.D |
| Phone |
0030265103294 |
| Email |
georgeconomou[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
Greece: Ethics Committee |
| Study type |
Observational
|
Clinical Trial 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.
Description:
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 reliable
indicators to allow safe release out of the hospital after the first 24 hours without risk
of hypocalcaemia. The measurement of parathyroid hormone (PTH) both intraoperative and
postoperatively (4 hours) is a hot topic in contemporary literature and promises accurate
predictions 13, but there is disagreement about the precise time of receiving the specimens
and great consideration about the increased cost 14, 15 (at our hospital is not even
available). An older, simple, fast and economical method is to measure levels of free serum
calcium 6,9. Despite that the correlation of the immediate post-operative levels of free
calcium, with the likelihood of developing hypocalcaemia has variations in different
surveys, resulting to early release of patients directly when free calcium is in normal
range, by some departments, while others follow strict protocols of monitoring patients for
days . However, the variation in the levels of free serum calcium between the first 6 and 12
postoperative hours alone or in combination with measurement of PTH seems to give some
answers and it is under great consideration in the international community.
It is therefore, in line with the current literature, important to develop a safe, and also
cost-effective protocol monitoring patients after total thyroidectomy, which, in combination
with predisposing risk factors of hypocalcaemia, will predict low-risk patients for
developing hypocalcaemia and allow secure release from the hospital.
PRIMARY OBJECTIVES:
The objective of this perspective study is to correlate the variability of the levels of
free serum calcium (Ca + +), and also the levels of albumin (ALB), phosphorus (PO-3),
magnesium (Mg) and total albumin (TPR), between two measurements on 6 and 12 hours
postoperatively, the incidence of hypocalcaemia in patients undergoing total thyroidectomy
for any reason. The aim is to develop on the basis of variation in levels of free serum
calcium, a secure method of prediction and identification of low risk patients for
developing hypocalcaemia providing an early release from hospital.
SECONDARY OBJECTIVES:
The correlation between development of hypocalcaemia in patients after total thyroidectomy
with the following factors:
- Gender,
- Age,
Intraoperative factors:
- Intraoperative recognition of parathyroid glands
- Possible autotransplantation of parathyroid glands
- Using scissors, ultrasonic Ligasure compared using ultrasonic scissors
- use Ultracision ligation
- Use of hemostatic
- Volume of blood loss;
- Volume and weight; preparation
Postoperative factors based on the histological-pathological report:
-Underlying thyroid pathology
CHOICE / NUMBER OF PATIENTS:
At least 80 patients with any thyroid pathology undergoing a total thyroidectomy regardless
of gender, age and medication preceding the one exception, patients treated with substitutes
calcium and vitamin D.
METHODS (CLINICAL-LABORATORY) The hypocalcaemia is defined in the study as clinical
hypocalcaemia. Required symptoms of hypocalcaemia are regional or perioral numbness and
signs of hypocalcaemia: Trousseau sign (karpopodic spasm) and Chvostek sign (spasm CN VII)
and / or the levels of free serum calcium below 0,5 mg / dl lower than the normal price
laboratory (8,2-10,6 mg / dl).
Each patient included in the study is provided with:
- Detailed preoperative history and physical examination. Recording; all preoperative
examinations before the introduction of the clinical (U / S thyroid scan, FNA biopsy)
- Receiving laboratory examinations
- Preoperative
- on the 6th, 12th and 24th postoperative hours,
- every 24 hours after the first 24 hours as long a patient remains in clinical
- at least 7 days after hospital discharge
- The laboratory control, includes
1. pre-operatively and 6hr postoperatively :
- Complete blood count,
- levels of urea,
- creatinine,
- sodium potassium,
- glucose, -
- albumin,
- total protein, -
- transaminases,
- γ-GT,
- total and immediate cholerethrini,
- alkaline phosphatase,
- lactate dehydrogenase,
- amylase,
- free serum calcium,
- phosphorus,
- magnesium
2. Ιn all other measurements:
- Free serum calcium,
- phosphorus,
- magnesium,
- albumin and
- total albumin levels
- Surgery information, detailed references of:
1. The time of onset and completion of surgery
2. The use of ligation, Ligasure ultrasonic scissors or Harmonic
3. The recognition of intraoperative parathyroid glands, their number and their
potential autologous transplants
4. The weight of the specimen
5. The blood loss (large or small)
6. The use of hemostatics
7. The use neuromonitoring
8. The type of antibiotics used
9. The technical rehabilitation of the skin and the use of skin glue
10. The installation of vacuum drainage
- Detailed list of all medication received by the patient during hospitalization
- No intravenous or oral calcium or vitamin D supplementation before completing 12 hours
postoperatively except the clinical case of development of significant hypocalcaemia.
- Detailed clinical examination, including:
1. Testing for Regional numbness
2. Monitored for signs of Chvostek and Trousseau
3. Detailed analysis of the histological-pathological report with a detailed record
of findings of the final pathology of the thyroid.
