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NCT Number: NCT07625865

Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases

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.

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Key information

Conditions

Benign Thyroid Nodule

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, 61111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years)
  • Benign thyroid disease confirmed by: clinical assessment, ultrasonography, and fine-needle aspiration cytology (Bethesda II)
  • Indicated for elective hemithyroidectomy or total thyroidectomy
  • 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)

Treatment and study plan

sutureless thyroidectomy without drain

Procedure

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.

sutureless thyroidectomy with drain

Procedure

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.

Primary outcomes

  1. Incidence of postoperative neck hematoma requiring intervention

    Time frame: Within 48 hours postoperatively

    Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation

Secondary outcomes

  1. 1. Overall postoperative complication rate

    Time frame: Within 30 days postoperatively

    Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury

  2. 2. Seroma formation

    Time frame: Within 14 days postoperatively

    Clinically or ultrasonographically detected fluid collection requiring aspiration

  3. 3. Postoperative hypocalcemia

    Time frame: Within 72 hours postoperatively

    Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation

  4. Recurrent laryngeal nerve injury

    Time frame: Within 30 days postoperatively

    Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Safety and Feasibility of Drainless Thyroid Surgery for Benign Thyroid Diseases Using the Sutureless Technique, Rrandomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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