Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy

Sponsor
Imam Mohammad ibn Saud Islamic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05684536
Collaborator
(none)
20
2
2.5

Study Details

Study Description

Brief Summary

To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

Condition or Disease Intervention/Treatment Phase
  • Device: liagsure device
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Liagure Safety in Thyroidectomy With Conventional Thyroidectomy
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-operative complications [Postoperatively from day of surgery until one week post operatively]

    Including RLN palsy , hypocalcemia , hemorrhage wound infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imam Mohammad ibn Saud Islamic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mohammad bukhetan alharbi, associate professor, Imam Mohammad ibn Saud Islamic University
ClinicalTrials.gov Identifier:
NCT05684536
Other Study ID Numbers:
  • ligasure safety thyroidectomy
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023