Benign Thyroid Nodule
Conditions
Brief summary
This randomized controlled trial evaluates the safety and feasibility of drainless thyroid surgery for benign thyroid diseases using a sutureless hemostatic technique. Patients undergoing thyroidectomy are randomized to either drainless surgery or surgery with drain placement. The study compares postoperative outcomes, including complications, pain, hospital stay, and need for reintervention.
Detailed description
Thyroidectomy for benign thyroid diseases is commonly performed with routine placement of surgical drains to prevent postoperative hematoma or seroma. However, drain use may be associated with increased pain, infection risk, prolonged hospital stay, and patient discomfort. Advances in surgical techniques, particularly the use of sutureless energy-based hemostatic devices, have raised the possibility of safely omitting routine drain placement in selected patients. This prospective randomized controlled trial aims to assess the safety and feasibility of drainless thyroid surgery in patients with benign thyroid diseases. Eligible patients undergoing thyroidectomy are randomly allocated into two groups: a drainless group, in which no postoperative drain is inserted, and a control group, in which a conventional closed suction drain is placed. All surgeries are performed using a standardized sutureless technique for hemostasis. Patients are followed postoperatively to evaluate surgical and clinical outcomes, including postoperative bleeding or hematoma, seroma formation, wound complications, hypocalcemia, recurrent laryngeal nerve injury, postoperative pain, length of hospital stay, and need for reintervention or readmission. The results of this study are expected to clarify whether drainless thyroid surgery using a sutureless technique is a safe and feasible alternative to conventional drain placement in benign thyroid surgery and may help optimize postoperative care and patient comfort
Interventions
PROCEDUREsutureless thyroidectomy without drain
Participants undergo sutureless thyroidectomy procedure but no drain is placed postoperatively. The goal is to assess whether omitting the drain affects postoperative outcomes such as pain, seroma, hematoma, infection, or overall recovery, while maintaining safety.
PROCEDUREsutureless thyroidectomy with drain
Participants undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain. The drain is intended to evacuate postoperative fluid (blood or serous fluid) to reduce the risk of complications such as hematoma or seroma formation. The surgical technique itself follows conventional sutureless thyroidectomy principles.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients (≥18 years) 2. Benign thyroid disease confirmed by: clinical assessment, ultrasonography, and fine-needle aspiration cytology (Bethesda II) 3. Indicated for elective hemithyroidectomy or total thyroidectomy 4. Euthyroid or adequately controlled thyroid function
Exclusion criteria
* Thyroid malignancy or indeterminate cytology * Re-operative thyroid surgery * Retrosternal goiter * Coagulation disorders * Patients on anticoagulation that could not be safely discontinued * Concomitant neck surgery * Severe uncontrolled systemic illness (ASA IV or higher)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative neck hematoma requiring intervention | Within 48 hours postoperatively | Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Overall postoperative complication rate | Within 30 days postoperatively | Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury |
| 2. Seroma formation | Within 14 days postoperatively | Clinically or ultrasonographically detected fluid collection requiring aspiration |
| 3. Postoperative hypocalcemia | Within 72 hours postoperatively | Corrected serum calcium \< 8.5 mg/dL and/or symptoms requiring calcium supplementation |
| Recurrent laryngeal nerve injury | Within 30 days postoperatively | Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy |
Countries
Egypt
Outcome results
None listed