Trial Outcomes & Findings for A Comparative Analysis of Hypocalcemia Incidence in Patients Undergoing Thyroidectomy: Ligasure vs Conventional Ligation of Vessels by Knot Tying (NCT NCT06716632)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

2 Days

Results posted on

2025-06-10

Participant Flow

Time Period/Location:Surgical Department, Gulab Devi Hospital, Lahore, from April 2024 to March 2025. Methodology: Seventy-six patients who underwent thyroidectomy were randomly allocated using lottery method to the LigaSure (38) and conventional knot-tying (38) groups.

Participant milestones

Participant milestones
Measure	Ligasure 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	Knot Tying Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers
Overall Study STARTED	38	38
Overall Study COMPLETED	38	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ligasure n=38 Participants 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	Knot Tying n=38 Participants Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers	Total n=76 Participants Total of all reporting groups
Age, Customized Age	37.89 years n=38 Participants	39.29 years n=38 Participants	38.59 years n=76 Participants
Sex: Female, Male Female	17 Participants n=38 Participants	23 Participants n=38 Participants	40 Participants n=76 Participants
Sex: Female, Male Male	21 Participants n=38 Participants	15 Participants n=38 Participants	36 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Pakistan	38 participants n=38 Participants	38 participants n=38 Participants	76 participants n=76 Participants
Hypocalcemia	4 Participants n=38 Participants	3 Participants n=38 Participants	7 Participants n=76 Participants

PRIMARY outcome

Timeframe: 2 Days

Outcome measures

Outcome measures
Measure	Ligasure n=38 Participants 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 Using Ligasure for heamostasis: 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.	Knot Tying n=38 Participants Conventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers Use of conventional knot tying technique for heamostasis: 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.
Number of Participants With Hypocalcemia	4 participants	3 participants

Adverse Events

Ligasure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Knot Tying

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zain Himayoun

Gulab Devi Hospital, Lahore

Phone: 03043862033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place