Ligature; HemorrhageNCT05684536
Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
A study testing liagsure device in people with Ligature; Hemorrhage and Recurrent Laryngeal Nerve Injuries, run by Imam Mohammad ibn Saud Islamic University.
Trial summary
To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping . Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ligature; Hemorrhage, Recurrent Laryngeal Nerve Injuries, Hypocalcemia
- What is being tested?
- liagsure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
- Any age
- -
Who cannot join
- patient undergoing re-do surgery " completion thyroidectomy "
- patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
About this study
To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .
Read the detailed description
Due to the high vascularity of the thyroid gland and the relatively tiny operative field, rigorous hemostasis is an essential requirement for successful thyroid surgery. Blood vessel ligation and/or ligation are the primary means of attaining hemostasis in thyroidectomy. New technologies have been developed, including a vessel sealing device (ligasure) that seals vessels by fusing the inner layers of the vessel wall with minimal amounts of thermal dispersion burning and tissue friction, thereby minimizing the occurrence of unintentional burns.
yet. It is unclear whether the heat conveyed by a ligature can harm the recurrent laryngeal nerve due to its proximity to the berry ligament.
thromosis of the inferior parathyroidal gland's supplying artery during dissection may result from alternative prospective delineation of the inferior thyroidal artery using ligasure for dissection.
The purpose of this study is to assess the safety and efficacy of ligasure with standard vascular ligation in open thyroid surgery.
- Being tested
- liagsure device
- Medical subject headings
- Hemorrhage, Recurrent Laryngeal Nerve Injuries, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liagsure deviceDevice
the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery
| Study group | Role | What they receive |
|---|---|---|
| ligasure throidectomy | Active comparator | the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery Receives: Device: liagsure device |
| conventional thyroidectomy | No intervention | with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Including RLN palsy , hypocalcemia , hemorrhage wound infection
Measured: Postoperatively from day of surgery until one week post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligature; HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Mohammad ibn Saud Islamic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad bukhetan alharbi, Imam Mohammad ibn Saud Islamic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684536
- Sponsor's protocol ID
- ligasure safety thyroidectomy
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
- ClinicalTrials.gov ID
- NCT05684536
- Acronym / sponsor ID
- ligasure safety thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imam Mohammad ibn Saud Islamic UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .
Detailed description
Due to the high vascularity of the thyroid gland and the relatively tiny operative field, rigorous hemostasis is an essential requirement for successful thyroid surgery. Blood vessel ligation and/or ligation are the primary means of attaining hemostasis in thyroidectomy. New technologies have been developed, including a vessel sealing device (ligasure) that seals vessels by fusing the inner layers of the vessel wall with minimal amounts of thermal dispersion burning and tissue friction, thereby minimizing the occurrence of unintentional burns.
yet. It is unclear whether the heat conveyed by a ligature can harm the recurrent laryngeal nerve due to its proximity to the berry ligament.
thromosis of the inferior parathyroidal gland's supplying artery during dissection may result from alternative prospective delineation of the inferior thyroidal artery using ligasure for dissection.
The purpose of this study is to assess the safety and efficacy of ligasure with standard vascular ligation in open thyroid surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ligasure throidectomy | Active comparator | Device: liagsure devicethe vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery |
| conventional thyroidectomy | No intervention | –with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
- Any age
- -
Key exclusion criteria (2 listed)
- patient undergoing re-do surgery " completion thyroidectomy "
- patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liagsure devicethe vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery | Device | ligasure throidectomy |
Primary outcome
Post-operative complications
Time frame: Postoperatively from day of surgery until one week post operatively
Including RLN palsy , hypocalcemia , hemorrhage wound infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing liagsure device in people with Ligature; Hemorrhage and Recurrent Laryngeal Nerve Injuries, run by Imam Mohammad ibn Saud Islamic University.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Post-operative complications (time frame: Postoperatively from day of surgery until one week post operatively). 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 13 Jan 2023.