LigaSure vs Bipolar Diathermy in Thyroidectomy

NCT ID: NCT07274891

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-01-01

Brief Summary

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Comparative Evaluation of LigaSure Versus Conventional Bipolar Diathermy in Thyroid Surgery: Operative and Postoperative Outcome.

Detailed Description

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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

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Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thyroidectomy using LigaSure

Group Type ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type PROCEDURE

Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.

LigaSure

Intervention Type PROCEDURE

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.

Thyroidectomy using bipolar diathermy

Group Type ACTIVE_COMPARATOR

bipolar diathermy

Intervention Type PROCEDURE

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.

Thyroidectomy

Intervention Type PROCEDURE

Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.

Interventions

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bipolar diathermy

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.

Intervention Type PROCEDURE

Thyroidectomy

Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.

Intervention Type PROCEDURE

LigaSure

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (≥18 years) undergoing partial or total thyroidectomy.
2. Diagnosed with benign or low-risk malignant thyroid disorders.
3. Fit for general anesthesia.
4. Provided written informed consent to participate in the study.

Exclusion Criteria

1.Previous neck surgery or radiotherapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Keroles Atef Shaffik Nassem

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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

Reference Type RESULT

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

Reference Type RESULT

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

Reference Type RESULT

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

Reference Type RESULT

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 9602010 (View on PubMed)

Dionigi 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

Reference Type RESULT

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

Reference Type RESULT

Other Identifiers

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CELVBDTSCSUE

Identifier Type: -

Identifier Source: org_study_id

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