ThyroidectomyNCT07274891
LigaSure vs Bipolar Diathermy in Thyroidectomy
A study testing LigaSure, bipolar diathermy and Thyroidectomy in people with Thyroidectomy, run by Assiut University.
Trial summary
Comparative Evaluation of LigaSure Versus Conventional Bipolar Diathermy in Thyroid Surgery: Operative and Postoperative Outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- LigaSure, bipolar diathermy and Thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) undergoing partial or total thyroidectomy.
- Diagnosed with benign or low-risk malignant thyroid disorders.
- Fit for general anesthesia.
- Provided written informed consent to participate in the study.
Who cannot join
- 1.Previous neck surgery or radiotherapy.
About this study
Official title: Comparative Evaluation of LigaSure Versus Bipolar Diathermy in Thyroidectomy: A Single-Center Study From Upper Egyp
Comparative Evaluation of LigaSure Versus Conventional Bipolar Diathermy in Thyroid Surgery: Operative and Postoperative Outcome.
Read the detailed description
Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders. Achieving precise hemostasis is essential to minimize intraoperative bleeding, preserve vital structures such as the recurrent laryngeal nerve and parathyroid glands, and prevent complications like hematoma and infection. Conventional bipolar diathermy has long been used to achieve hemostasis, but it can result in greater lateral thermal spread, prolonged operative time, and potential thermal injury to adjacent tissues.
LigaSure, an advanced vessel sealing system, combines pressure and energy to achieve permanent vessel fusion and can seal vessels up to 7 mm in diameter with minimal lateral thermal damage. Its use in thyroid surgery has been associated with improved surgical field visibility, reduced intraoperative bleeding, and shorter operative time compared to bipolar diathermy.
Additionally, LigaSure may lower the risk of postoperative complications, including transient hypocalcemia and recurrent laryngeal nerve palsy, due to its precise energy delivery and limited collateral damage.
However, existing studies have shown variable results regarding the magnitude of these benefits, and the cost-effectiveness of LigaSure compared with conventional bipolar diathermy remains uncertain. Therefore, a prospective randomized controlled trial is required to provide conclusive evidence regarding its role in reducing operative time and postoperative complications during thyroidectomy.
- Conditions
- Thyroidectomy
- Being tested
- LigaSure, bipolar diathermy, Thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSureProcedure or surgery
LigaSure is an advanced vessel-sealing system that uses pressure and bipolar energy with real-time feedback to seal vessels up to 7 mm. It limits thermal spread, provides consistent sealing, and reduces the need for sutures-making it distinct from standard bipolar diathermy and other energy devices.
bipolar diathermyProcedure or surgery
Bipolar diathermy uses two closely spaced electrodes to deliver controlled coagulation and cutting with minimal current spread. Unlike LigaSure or other advanced sealing devices, it lacks an automatic feedback system and does not fuse larger vessels, relying instead on direct thermal coagulation. It is simple, widely available, cost-effective, and suitable mainly for small-vessel hemostasis.
ThyroidectomyProcedure or surgery
Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.
| Study group | Role | What they receive |
|---|---|---|
| Thyroidectomy using LigaSure | Active comparator | Not described Receives: Procedure: LigaSure; Procedure: Thyroidectomy |
| Thyroidectomy using bipolar diathermy | Active comparator | Not described Receives: Procedure: bipolar diathermy; Procedure: Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Total time (from skin to skin)Time taken for dissection and haemostasis
Measured: during surgery 2 hours
Number of ligatures used
Measured: during surgery
Secondary outcomes (2)
Postoperative pain
Pain assessment through the VAS was explained to the patient (through selection of the number that represents his/her pain with 0 = no pain, and 10 = worst pain
Measured: 24 hours postoperative
Transient or permanent hypocalcaemia
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keroles Atef Shaffik Nassem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274891
- Sponsor's protocol ID
- CELVBDTSCSUE
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali Alnnaser, Sulaiman J, Alloush A. A Comparative Study Between Total Thyroidectomy with Ligasure and Total Conventional Thyroidectomy. SRG International Journal of Medical Science. 2024 May;11(3):1-4
Lee J, Nah KY, Kim RM, Ahn YH, Soh EY, Park CS. Comparison of the harmonic scalpel, LigaSure, and conventional technique in open thyroidectomy. Ann Surg Treat Res. 2016;90(2):61-66
Markogiannakis H, Kekis PB, Memos N, Chatzimavroudis G, Lagoudianakis EE, Manouras A. Thyroid surgery using the electrothermal bipolar vessel sealing system. World J Surg. 2011;35(9):1962-1968
Sakorafas GH, Stafyla V, Bramis K, Kotsifopoulos N, Kassaras GA. Ligasure versus clamp-and-tie thyroidectomy: a comparative study. Eur Surg Res. 2008;41(3):182-186
Lachanas VA, Prokopakis EP, Mpenakis AA, Karatzanis AD, Velegrakis GA. LigaSure versus bipolar coagulation in total thyroidectomy. Am J Otolaryngol. 2014;35(6):766-770
Kennedy JS, Stranahan PL, Taylor KD, Chandler JG. High-burst-strength, feedback-controlled bipolar vessel sealing. Surg Endosc. 1998 Jun;12(6):876-8. doi: 10.1007/s004649900733.
PubMed 9602010Dionigi G, Rovera F, Boni L, Castano P, Dionigi R. Electrothermal bipolar vessel sealing system (LigaSure) in thyroid surgery: a prospective, randomized study. Head Neck. 2010;32(6):718-722
Yao HS, Wang Q, Wang WJ, Li J, Jin JW, Ma YY. A meta-analysis of LigaSure vs conventional vessel ligation in thyroidectomy. Surg Today. 2013;43(4):370-378
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of LigaSure Versus Bipolar Diathermy in Thyroidectomy: A Single-Center Study From Upper Egyp
- ClinicalTrials.gov ID
- NCT07274891
- Acronym / sponsor ID
- CELVBDTSCSUE
- Conditions
- Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Dec 2025 (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.
Comparative Evaluation of LigaSure Versus Conventional Bipolar Diathermy in Thyroid Surgery: Operative and Postoperative Outcome.
Detailed description
Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders. Achieving precise hemostasis is essential to minimize intraoperative bleeding, preserve vital structures such as the recurrent laryngeal nerve and parathyroid glands, and prevent complications like hematoma and infection. Conventional bipolar diathermy has long been used to achieve hemostasis, but it can result in greater lateral thermal spread, prolonged operative time, and potential thermal injury to adjacent tissues.
LigaSure, an advanced vessel sealing system, combines pressure and energy to achieve permanent vessel fusion and can seal vessels up to 7 mm in diameter with minimal lateral thermal damage. Its use in thyroid surgery has been associated with improved surgical field visibility, reduced intraoperative bleeding, and shorter operative time compared to bipolar diathermy.
Additionally, LigaSure may lower the risk of postoperative complications, including transient hypocalcemia and recurrent laryngeal nerve palsy, due to its precise energy delivery and limited collateral damage.
However, existing studies have shown variable results regarding the magnitude of these benefits, and the cost-effectiveness of LigaSure compared with conventional bipolar diathermy remains uncertain. Therefore, a prospective randomized controlled trial is required to provide conclusive evidence regarding its role in reducing operative time and postoperative complications during thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroidectomy using LigaSure | Active comparator | Procedure: LigaSure, Procedure: Thyroidectomy |
| Thyroidectomy using bipolar diathermy | Active comparator | Procedure: bipolar diathermy, Procedure: Thyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) undergoing partial or total thyroidectomy.
- Diagnosed with benign or low-risk malignant thyroid disorders.
- Fit for general anesthesia.
- Provided written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- 1.Previous neck surgery or radiotherapy.
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 |
|---|---|---|
| LigaSureLigaSure is an advanced vessel-sealing system that uses pressure and bipolar energy with real-time feedback to seal vessels up to 7 mm. It limits thermal spread, provides consistent sealing, and reduces the need for sutures-making it distinct from standard bipolar diathermy and other energy devices. | Procedure or surgery | Thyroidectomy using LigaSure |
| bipolar diathermyBipolar diathermy uses two closely spaced electrodes to deliver controlled coagulation and cutting with minimal current spread. Unlike LigaSure or other advanced sealing devices, it lacks an automatic feedback system and does not fuse larger vessels, relying instead on direct thermal coagulation. It is simple, widely available, cost-effective, and suitable mainly for small-vessel hemostasis. | Procedure or surgery | Thyroidectomy using bipolar diathermy |
| ThyroidectomyThyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders. | Procedure or surgery | Thyroidectomy using LigaSure, Thyroidectomy using bipolar diathermy |
Primary outcome
Operative time
Time frame: during surgery 2 hours
Total time (from skin to skin)Time taken for dissection and haemostasis
Number of ligatures used
Time frame: during surgery
2 secondary outcomes
Postoperative pain
Time frame: 24 hours postoperative
Transient or permanent hypocalcaemia
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publicationAli Alnnaser, Sulaiman J, Alloush A. A Comparative Study Between Total Thyroidectomy with Ligasure and Total Conventional Thyroidectomy. SRG International Journal of Medical Science. 2024 May;11(3):1-4
- Results publicationLee J, Nah KY, Kim RM, Ahn YH, Soh EY, Park CS. Comparison of the harmonic scalpel, LigaSure, and conventional technique in open thyroidectomy. Ann Surg Treat Res. 2016;90(2):61-66
- Results publicationMarkogiannakis H, Kekis PB, Memos N, Chatzimavroudis G, Lagoudianakis EE, Manouras A. Thyroid surgery using the electrothermal bipolar vessel sealing system. World J Surg. 2011;35(9):1962-1968
- Results publicationSakorafas GH, Stafyla V, Bramis K, Kotsifopoulos N, Kassaras GA. Ligasure versus clamp-and-tie thyroidectomy: a comparative study. Eur Surg Res. 2008;41(3):182-186
- Results publicationLachanas VA, Prokopakis EP, Mpenakis AA, Karatzanis AD, Velegrakis GA. LigaSure versus bipolar coagulation in total thyroidectomy. Am J Otolaryngol. 2014;35(6):766-770
- Results publication: PubMed 9602010Kennedy JS, Stranahan PL, Taylor KD, Chandler JG. High-burst-strength, feedback-controlled bipolar vessel sealing. Surg Endosc. 1998 Jun;12(6):876-8. doi: 10.1007/s004649900733.
- Results publicationDionigi G, Rovera F, Boni L, Castano P, Dionigi R. Electrothermal bipolar vessel sealing system (LigaSure) in thyroid surgery: a prospective, randomized study. Head Neck. 2010;32(6):718-722
- Results publicationYao HS, Wang Q, Wang WJ, Li J, Jin JW, Ma YY. A meta-analysis of LigaSure vs conventional vessel ligation in thyroidectomy. Surg Today. 2013;43(4):370-378
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LigaSure, bipolar diathermy and Thyroidectomy in people with Thyroidectomy, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Operative time (time frame: during surgery 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274891, which also lists 8 linked publications.
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 10 Dec 2025.