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LigaSure vs Bipolar Diathermy in Thyroidectomy

A

Assiut University

Status

Not yet enrolling

Conditions

Thyroidectomy

Treatments

Procedure: Thyroidectomy
Procedure: LigaSure
Procedure: bipolar diathermy

Study type

Interventional

Funder types

Other

Identifiers

NCT07274891
CELVBDTSCSUE

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Thyroidectomy using LigaSure
Active Comparator group
Treatment:
Procedure: LigaSure
Procedure: Thyroidectomy
Thyroidectomy using bipolar diathermy
Active Comparator group
Treatment:
Procedure: bipolar diathermy
Procedure: Thyroidectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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