Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410937
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-02
Brief Title:
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
In all thyroid surgeries many surgeons utilize drains on a regular basis and have done so for years according to recommendations Due to the thyroids high vascularization throughout its endocrine function any haemorrhage inside the closed paratracheal space has the potential to impede venous and lymphatic drainage which might result in airway blockage and laryngopharyngeal oedema Surgeons routinely perform post-operative thyroid gland draining in the modern surgical field The goal is to stop fluid from accumulating in the surgical wound site which could constrict the patients trachea and jeopardize their life
Thyroid storm hypocalcemia hematomahaemorrhage impairing airway recurrent or superior laryngeal nerve damage and wound problems such as wound infection are among the main post-operative consequences of thyroid surgery
Some reports indicate the use of drains following thyroid surgery is not very beneficial Some researchers have been prompted by this to consider whether drains should be inserted during thyroid surgery in which several research papers and meta-analyses have also failed to demonstrate the benefit of drainage in thyroid surgery Blood clots in the drains could cause severe post-operative bleeding preventing the surgeon from being notified Difficult thyroidectomy cases might be predicted by factors linked to the patient the thyroid or the surgeon
When thyroidectomies are performed under ideal conditions-that is in a setting where good anatomical and physiological expertise is matched with meticulous surgical skills-complications are rare The ability of the surgeon to do a thyroid surgery without difficulties is crucial It is not possible to see routine drain use as a substitute for these components
Percutaneous drains are frequently used in head and neck surgery cases However although effective at preventing post-operative haematoma formation their use can also be associated with significant complications including infection fistulae pain psychosocial implications and most notably prolongation of hospital stay
Accordingly some researchers that reject the use of intraoperative drains there isnt a very high rate of wound hemorrhages following thyroid surgery Additionally other research indicates that there is no difference in the two groups incidence of post-operative problems with and without drainage
Nearly all surgeons utilize a closed vacuum drain after the intervention to avoid the deadliest complication a smothering haemorrhage which several studies suggest may not be essential
Thyroid storm hypocalcemia hematomahaemorrhage impairing airway recurrent or superior laryngeal nerve damage and wound problems such as wound infection are among the main post-operative consequences of thyroid surgery
Some reports indicate the use of drains following thyroid surgery is not very beneficial Some researchers have been prompted by this to consider whether drains should be inserted during thyroid surgery in which several research papers and meta-analyses have also failed to demonstrate the benefit of drainage in thyroid surgery Blood clots in the drains could cause severe post-operative bleeding preventing the surgeon from being notified Difficult thyroidectomy cases might be predicted by factors linked to the patient the thyroid or the surgeon
When thyroidectomies are performed under ideal conditions-that is in a setting where good anatomical and physiological expertise is matched with meticulous surgical skills-complications are rare The ability of the surgeon to do a thyroid surgery without difficulties is crucial It is not possible to see routine drain use as a substitute for these components
Percutaneous drains are frequently used in head and neck surgery cases However although effective at preventing post-operative haematoma formation their use can also be associated with significant complications including infection fistulae pain psychosocial implications and most notably prolongation of hospital stay
Accordingly some researchers that reject the use of intraoperative drains there isnt a very high rate of wound hemorrhages following thyroid surgery Additionally other research indicates that there is no difference in the two groups incidence of post-operative problems with and without drainage
Nearly all surgeons utilize a closed vacuum drain after the intervention to avoid the deadliest complication a smothering haemorrhage which several studies suggest may not be essential
Detailed Description:
None
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