LigaSure vs Bipolar Diathermy in Thyroidectomy

December 8, 2025 updated by: Keroles Atef Shaffik Nassem, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thyroidectomy using LigaSure
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.
Procedure: Thyroidectomy
Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.
Active Comparator: Thyroidectomy using bipolar diathermy
Procedure: Thyroidectomy
Thyroidectomy is a standard surgical procedure for treating benign and malignant thyroid disorders.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: during surgery 2 hours
Total time (from skin to skin)Time taken for dissection and haemostasis
during surgery 2 hours
Number of ligatures used
Time Frame: during surgery
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 24 hours postoperative
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
24 hours postoperative
Transient or permanent hypocalcaemia
Time Frame: 24 hours postoperative
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
  • 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
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELVBDTSCSUE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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