Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04094493
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2019-09-17
Brief Title:
Vit D Role in Post Thyroidectomy Hypocalcemia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Role of Pre Operative Vit D Administiration in Decrease Incidence of Post Thyroidectomy Hypocalcemia
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypocalcemia after total thyroidectomy is usually transient but it is of main concern as it requires either prolonged stay in the hospital or readmission During the first 24 hours bleeding is the main complication but from the second day to six months transient hypocalcemia is of main concern Hypocalcemia can be evaluated symptomatically as well as from laboratory testing Signs and symptoms of hypocalcemia include numbness tingling and carpopedal spasm Preoperative vitamin D prevents postoperative transient hypocalcemia after thyroidectomy
Detailed Description:
Thyroid surgery is one of the most frequently performed surgical procedures worldwide Nowadays total thyroidectomy is the recommended procedure for thyroid disease As total thyroidectomy is the procedure of choice the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24 - which increases the morbidity rate and increases the length of hospitalization Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice postoperative hemorrhage dysphagia due to inflammation of the tissues surrounding the esophagus seroma formation Horners syndrome due to injury to the cervical sympathetic chain and poor healing of the wound with hypertrophy of the scar or wound infection
Advances in surgical techniques have evolved to preserve the parathyroid gland function which helps to prevent permanent hypocalcemia and its incidence now has reduced to 1-2 However transient hypoparathyroidism still occurs resulting in transient hypocalcemia It occurs due to the age parathyroid gland handling devascularization venous congestion post-surgical local site edema and neck dissection Prescribing preoperative vitamin D and calcium decreases the incidence of transient hypocalcemia after total thyroidectomy from 259 to 68 as compared to the control group
Total thyroidectomy is the procedure of choice in our population with the preservation of the parathyroid gland As transient hypocalcemia is common in post-thyroidectomy patients and increases the morbidity rate giving vitamin D and calcium preoperatively can reduce the burden of postoperative transient hypocalcemia and it will be helpful in decreasing the morbidity rate due to post-thyroidectomy transient hypocalcemia The objective of our study is to compare the frequency of transient hypocalcemia after vitamin D with the control group for patients undergoing total thyroidectomy
The study is based on patients with thyroid diseases who are indicated for total thyroidectomy Patients are divided into two groups group A who will recieve Vit D before operation and group B who wont Group A will be divided into
A1 no hypocacemia occurs with vit D A2 hypocalcemia occurs with vit D
Group B will be divided into
B1 no hypocacemia without vit D B2 hypocalcemia without vit D Comparison between the above mentioned four groups will determine the effectiveness of vit D in normalization of serum calcium levels after total thyroidectomy
Advances in surgical techniques have evolved to preserve the parathyroid gland function which helps to prevent permanent hypocalcemia and its incidence now has reduced to 1-2 However transient hypoparathyroidism still occurs resulting in transient hypocalcemia It occurs due to the age parathyroid gland handling devascularization venous congestion post-surgical local site edema and neck dissection Prescribing preoperative vitamin D and calcium decreases the incidence of transient hypocalcemia after total thyroidectomy from 259 to 68 as compared to the control group
Total thyroidectomy is the procedure of choice in our population with the preservation of the parathyroid gland As transient hypocalcemia is common in post-thyroidectomy patients and increases the morbidity rate giving vitamin D and calcium preoperatively can reduce the burden of postoperative transient hypocalcemia and it will be helpful in decreasing the morbidity rate due to post-thyroidectomy transient hypocalcemia The objective of our study is to compare the frequency of transient hypocalcemia after vitamin D with the control group for patients undergoing total thyroidectomy
The study is based on patients with thyroid diseases who are indicated for total thyroidectomy Patients are divided into two groups group A who will recieve Vit D before operation and group B who wont Group A will be divided into
A1 no hypocacemia occurs with vit D A2 hypocalcemia occurs with vit D
Group B will be divided into
B1 no hypocacemia without vit D B2 hypocalcemia without vit D Comparison between the above mentioned four groups will determine the effectiveness of vit D in normalization of serum calcium levels after total thyroidectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None