Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Thyroid Nodule
• Intervention / Treatment: Procedure: sutureless thyroidectomy without drain; Procedure: sutureless thyroidectomy with drain

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Minia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: thyroidectomy without drain; 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; 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.
Active Comparator: thyroidectomy with drain; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Overall postoperative complication rate	Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury	Within 30 days postoperatively
2. Seroma formation	Clinically or ultrasonographically detected fluid collection requiring aspiration	Within 14 days postoperatively
3. Postoperative hypocalcemia	Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation	Within 72 hours postoperatively
Recurrent laryngeal nerve injury	Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy	Within 30 days postoperatively

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): January 3, 2026

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: MUFMIRB9251023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be shared because the study contains sensitive clinical and surgical information. Sharing individual-level data may compromise participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No