A Comparative Analysis of Hypocalcemia Incidence in Patients Undergoing Thyroidectomy: Ligasure vs Conventional Ligation of Vessels by Knot Tying

NCT06716632 | Completed Results FDA Device

• 1 other identifier: AAMC/IRB/EA 41/2024
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of hypocalcemia in patients undergoing thyroidectomy using Ligasure versus conventional ligation of vessels by knot tying. Additionally, secondary outcomes such as operative time, intraoperative bleeding, length of hospital stay, and postoperative complications will be assessed to provide a holistic understanding of the two surgical approaches.

Conditions

Hypocalcemia After Total Thyroidectomy; Hypocalcemia

Keywords

thyroidectomy; hyocalcemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hypocalcemia

  2 Days

Study Arms (2)

Ligasure

EXPERIMENTAL

Ligasure is a bipolar vascular sealing system utilized to achieve effective control of bleeding and create a bloodless surgical environment. It operates by utilizing an electrical current within the frequency range of 2-4 MHz It induces denaturation of collagen and elastin within the vessels and surrounding tissues. The localized tissue temperatures typically range between 60-100°C, facilitating the fusion of collagen and elastin in the vessel walls. This fusion process creates a durable sealed zone without any carbonization and enables hemostasis in vessels with diameters of up to 7 mm

Device: Using Ligasure for heamostasis

Knot tying

EXPERIMENTAL

Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers

Procedure: Use of conventional knot tying technique for heamostasis

Interventions

Using Ligasure for heamostasis DEVICE

Ligasure is a bipolar vascular sealing system utilized to achieve effective control of bleeding and create a bloodless surgical environment. It operates by utilizing an electrical current within the frequency range of 2-4 MHz It induces denaturation of collagen and elastin within the vessels and surrounding tissues. The localized tissue temperatures typically range between 60-100°C, facilitating the fusion of collagen and elastin in the vessel walls. This fusion process creates a durable sealed zone without any carbonization and enables hemostasis in vessels with diameters of up to 7 mm.

Ligasure

Use of conventional knot tying technique for heamostasis PROCEDURE

Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers. While these techniques effectively control bleeding from vessels, they are time-consuming and carry the risk of harming adjacent structures like the recurrent and superior laryngeal nerves.

Knot tying

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients from both genders.
• Age between 20 years to 50 years.
• Patients undergoing Total thyroidectomy for benign thyroid disease.

You may not qualify if:

• Patients having pre-operative hypocalcaemia.
• Patients having malignant thyroid disease.
• Patients having recurrent thyroid disease.
• Patients having lobectomy + isthmectomy.
• Patients having pro-operative calcium supplements.

Sponsors & Collaborators

• Gulab Devi Hospital: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Results Point of Contact

• Title: Dr. Zain Himayoun
• Organization: Gulab Devi Hospital, Lahore

Zain.1080@gmail.com

03043862033

Study Officials

• M. Zia-ul-Miraj Ahmad Study Director, MBBS,FRCS

  Gulab Devi Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Post Graduate Resident)

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: April 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Locations

PA (1)