Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

January 5, 2023 updated by: mohammad bukhetan alharbi, Imam Mohammad ibn Saud Islamic University
To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study

Any age

-

Exclusion Criteria:

  • patient undergoing re-do surgery " completion thyroidectomy "

patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ligasure throidectomy
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
Device: liagsure device
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
No Intervention: conventional thyroidectomy
with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: Postoperatively from day of surgery until one week post operatively
Including RLN palsy , hypocalcemia , hemorrhage wound infection
Postoperatively from day of surgery until one week post operatively

Collaborators and Investigators

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

Sponsor

Imam Mohammad ibn Saud Islamic University

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 (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ligasure safety thyroidectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Hypocalcemia

Clinical Trials on liagsure device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe