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Hypocalcemia After Total ThyroidectomyTHYROIDECTOMYNCT06716632

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

A study testing Using Ligasure for heamostasis and Use of conventional knot tying technique for heamostasis in people with Hypocalcemia After Total Thyroidectomy and Hypocalcemia, run by Gulab Devi Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years
What is being tested?
Using Ligasure for heamostasis and Use of conventional knot tying technique for heamostasis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 sitePakistan
Study dates
20 Apr 2024to 20 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Gulab Devi Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
Using Ligasure for heamostasis, Use of conventional knot tying technique for heamostasis
Keywords
thyroidectomy, hyocalcemia
Medical subject headings
Hypocalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using Ligasure for heamostasisDevice

    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.

  • Use of conventional knot tying technique for heamostasisProcedure or surgery

    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.

Study groups in NCT06716632
Study groupRoleWhat they receive
LigasureExperimentalLigasure 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
Receives: Device: Using Ligasure for heamostasis
Knot tyingExperimentalConventional methods of vessel ligation, which involve the use of ties and suture ligatures, have long been employed in most medical centers
Receives: Procedure: Use of conventional knot tying technique for heamostasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Hypocalcemia

    Measured: 2 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start20 Apr 2024
  3. Primary completion20 Mar 2025
  4. Study completion20 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716632
Sponsor's protocol ID
AAMC/IRB/EA 41/2024
Acronym
THYROIDECTOMY
Status last verified
Jun 2025
First submitted
29 Nov 2024
Last updated
10 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Using Ligasure for heamostasis and Use of conventional knot tying technique for heamostasis in people with Hypocalcemia After Total Thyroidectomy and Hypocalcemia, run by Gulab Devi Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hypocalcemia (time frame: 2 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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