Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications

Not Applicable

Recruiting

• Conditions: Benign Thyroid Diseases
• Interventions: Procedure: thyroidectomy with drain; Procedure: thyroidectomy without drain

• Registration Number: NCT06410937
• Lead Sponsor: Sohag University

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 thyroid's 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 patient's trachea and jeopardize their life.

Thyroid storm, hypocalcemia, hematoma/haemorrhage 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 isn't 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

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18-60 years.
• Both sexes.
• Unilateral \ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy.

Exclusion Criteria

• Surgical contraindications such as coagulation dysfunction.
• Retrosternal goiter.
• A history of cervical surgery.
• Sever Co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease).
• Malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain used in the thyroid surgery	thyroidectomy with drain	-
No Drain used in the thyroid surgery	thyroidectomy without drain	-

Primary Outcome Measures

Name	Time	Method
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications	6 months	This study aims to compare the effectiveness of Drainless Versus Drainage after thyroidectomy operations regarding post-operative short-term surgical site complications as pain, infections, seroma, haematoma and gaping in patients with benign thyroid diseases.

Trial Locations

Locations (1)

Sohag University hospitals; 🇪🇬 Sohag, Egypt