Benign Thyroid NoduleNCT07625865
Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases
A study testing sutureless thyroidectomy without drain and sutureless thyroidectomy with drain in people with Benign Thyroid Nodule, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Benign Thyroid Nodule
- What is being tested?
- sutureless thyroidectomy without drain and sutureless thyroidectomy with drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2023to 3 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Benign Thyroid Nodule
- Being tested
- sutureless thyroidectomy without drain, sutureless thyroidectomy with drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureless thyroidectomy without drainProcedure or surgery
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 drainProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: sutureless thyroidectomy with drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative neck hematoma requiring intervention
Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation
Measured: Within 48 hours postoperatively
Secondary outcomes (4)
1. Overall postoperative complication rate
Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury
Measured: Within 30 days postoperatively
2. Seroma formation
Clinically or ultrasonographically detected fluid collection requiring aspiration
Measured: Within 14 days postoperatively
3. Postoperative hypocalcemia
Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation
Measured: Within 72 hours postoperatively
Recurrent laryngeal nerve injury
Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Oct 2023
- Primary completion20 Dec 2025
- Study completion3 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam M. Hamza, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625865
- Sponsor's protocol ID
- MUFMIRB9251023
- Status last verified
- Feb 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared because the study contains sensitive clinical and surgical information. Sharing individual-level data may compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Drainless Thyroid Surgery for Benign Thyroid Diseases Using the Sutureless Technique, Rrandomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07625865
- Acronym / sponsor ID
- MUFMIRB9251023
- Conditions
- Benign Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 3 Jan 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyroidectomy without drain | Active comparator | Procedure: sutureless thyroidectomy without drainParticipants 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. |
| thyroidectomy with drain | Active comparator | Procedure: sutureless thyroidectomy with drainParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Thyroid malignancy or indeterminate cytology
- Re-operative thyroid surgery
- Retrosternal goiter
- Coagulation disorders
- Patients on anticoagulation that could not be safely discontinued
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sutureless thyroidectomy without drainParticipants 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. | Procedure or surgery | thyroidectomy without drain |
| sutureless thyroidectomy with drainParticipants 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. | Procedure or surgery | thyroidectomy with drain |
Primary outcome
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
4 secondary outcomes
1. Overall postoperative complication rate
Time frame: Within 30 days postoperatively
2. Seroma formation
Time frame: Within 14 days postoperatively
3. Postoperative hypocalcemia
Time frame: Within 72 hours postoperatively
Recurrent laryngeal nerve injury
Time frame: Within 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared because the study contains sensitive clinical and surgical information. Sharing individual-level data may compromise participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sutureless thyroidectomy without drain and sutureless thyroidectomy with drain in people with Benign Thyroid Nodule, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative neck hematoma requiring intervention (time frame: Within 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.