NCT07274891

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

December 8, 2025

Conditions

Thyroidectomy

Outcome Measures

Primary Outcomes (2)

  • Operative time

    Total time (from skin to skin)Time taken for dissection and haemostasis

    during surgery 2 hours

  • Number of ligatures used

    during surgery

Secondary Outcomes (2)

  • Postoperative pain

    24 hours postoperative

  • Transient or permanent hypocalcaemia

    24 hours postoperative

Study Arms (2)

Thyroidectomy using LigaSure

ACTIVE COMPARATOR
Procedure: LigaSureProcedure: Thyroidectomy

Thyroidectomy using bipolar diathermy

ACTIVE COMPARATOR
Procedure: bipolar diathermyProcedure: Thyroidectomy

Interventions

LigaSurePROCEDURE

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 LigaSure
bipolar diathermyPROCEDURE

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 using bipolar diathermy
ThyroidectomyPROCEDURE

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

Thyroidectomy using LigaSureThyroidectomy using bipolar diathermy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous neck surgery or radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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

    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

    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

    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

    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

    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.

    PMID: 9602010RESULT

  • 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

    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

    RESULT

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 10, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

December 10, 2025

Record last verified: 2025-12