Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases

NCT07625865 | Completed

• 1 other identifier: MUFMIRB9251023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative neck hematoma requiring intervention

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

  Within 48 hours postoperatively

Secondary Outcomes (4)

• 1. Overall postoperative complication rate

  Within 30 days postoperatively

• 2. Seroma formation

  Within 14 days postoperatively

• 3. Postoperative hypocalcemia

  Within 72 hours postoperatively

• Recurrent laryngeal nerve injury

  Within 30 days postoperatively

Study Arms (2)

thyroidectomy without drain

ACTIVE COMPARATOR

Participants in this arm undergo sutureless thyroidectomy procedure, but no surgical drain is placed afterward. The aim is to evaluate whether omitting the drain affects outcomes such as postoperative surgical site complications (like pain, infection, seroma, hematoma) compared with the drained approach.

Procedure: sutureless thyroidectomy without drain

thyroidectomy with drain

ACTIVE COMPARATOR

Participants in this arm undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain at the end of the procedure. The purpose of using the drain is to evacuate any postoperative fluid such as blood or serous fluid from the surgical site to theoretically reduce complications such as hematoma or seroma accumulation.

Procedure: sutureless thyroidectomy with drain

Interventions

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.

thyroidectomy without drain

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.

thyroidectomy with drain

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: October 20, 2023
• Primary Completion: December 20, 2025
• Study Completion: January 3, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-02

Locations

EG (1)