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

June 6, 2025 updated by: Zain Himayoun, Gulab Devi Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Thyroidectomy is surgical removal of all or part of the thyroid gland, which is located in the front of the neck. Depending on how much thyroid tissue is removed, thyroidectomy could be classified into Total thyroidectomy, subtotal thyroidectomy, near total thyroidectomy and lobectomy.

In total thyroidectomy, the entire thyroid gland is removed. In thyroid lobectomy, one lobe of the thyroid gland is removed. In Thyroid lobectomy with isthmectomy, thyroid lobe along with the isthmus is removed. In Subtotal thyroidectomy, a small portion of the thyroid gland is left during the surgery. This portion is near the trachea, parathyroid glands and the recurrent laryngeal nerve. Indications for thyroidectomy are thyroid cancer, MNG, solitary thyroid nodule.

Complications of thyroidectomy include hoarseness or change in voice (33.3%), damage to parathyroid glands causing hypocalcaemia (54.4%), wound infection (3.4%), dysphagia (32.8%). Several risk factors may contribute to the occurrence of post-thyroidectomy complications, including age, gender, enlarged gland size, type of thyroid disease, presence of fibrosis and inflammation, extent of thyroidectomy, and lymph node dissection. Among these complications, hypocalcaemia and recurrent laryngeal nerve injury are the most frequently observed.

The superior and inferior parathyroid glands, located near the thyroid gland, play a vital role in calcium homeostasis by producing parathyroid hormone (PTH), which regulates calcium levels in the bloodstream.

Hypocalcemia, characterized by low serum calcium levels. It is a frequent and significant complication of thyroidectomy due to damage, ischemia, or removal of one or more of the parathyroid glands during surgery. It can be categorized into two main types, transient hypocalcemia and permanent hypocalcemia. The primary difference between these two types lies in the duration. Transient hypocalcemia lasts for 3 months after surgery, while permanent hypocalcemia persists for 3 months or longer after surgery.

To minimize the risk of parathyroid gland damage, various surgical techniques have been developed, including the utilization of energy-based devices such as Ligasure. Ligasure has gained popularity in thyroidectomy procedures due to its potential advantages in terms of precision, hemostasis, and reduced operative time.

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.

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. In light of the growing demand for time-saving procedures, particularly in high-volume operating theaters where efficient patient turnover is essential, there is a growing interest in devices or techniques that minimize the reliance on conventional knot-tying or suture ligation for achieving hemostasis. This is particularly important to optimise anesthesia time and improve overall efficiency.

According to a recent study, hypocalcemia occurred in 6.7% of individuals who underwent surgery using the Liga Sure method. In a separate study, 32.4% of patients who had surgery utilising the traditional knot tying technique experienced hypocalcemia.

However, despite the increasing use of Ligasure and other energy devices, there is a paucity of research comparing their efficacy in preventing hypocalcemia after thyroidectomy.

Therefore, 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 the conventional artery forceps/knot tying technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Gulab Devi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients having pre-operative hypocalcaemia.
  2. Patients having malignant thyroid disease.
  3. Patients having recurrent thyroid disease.
  4. Patients having lobectomy + isthmectomy.
  5. Patients having pro-operative calcium supplements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: 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.
Experimental: Knot tying
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants With Hypocalcemia
Time Frame: 2 Days
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gulab Devi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: M. Zia-ul-Miraj Ahmad Study Director, MBBS,FRCS, Gulab Devi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAMC/IRB/EA 41/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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