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LigaSure vs Bipolar Diathermy in Thyroidectomy

Comparative Evaluation of LigaSure Versus Bipolar Diathermy in Thyroidectomy: A Single-Center Study From Upper Egyp

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07274891
Enrollment
30
Registered
2025-12-10
Start date
2025-12-01
Completion date
2027-01-01
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

Brief summary

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.

Interventions

PROCEDURELigaSure

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 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.

PROCEDUREThyroidectomy

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Operative timeduring surgery 2 hoursTotal time (from skin to skin)Time taken for dissection and haemostasis
Number of ligatures usedduring surgery

Secondary

MeasureTime frameDescription
Postoperative pain24 hours postoperativePain 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
Transient or permanent hypocalcaemia24 hours postoperative

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026