Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy

January 6, 2020 updated by: Abadeer Raafat Marsis Rizallah, Assiut University

Comparative Study Between Ligasure Versus Conventional Vessel Ligation in Thyroidectomy " Randomised Controlled Study"

To compare between ligasure versus conventional vessel ligation in thyroidectomy as regards intraoperative and post operative complications rate

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The significant vascularity of the thyroid gland and the relatively small operative field makes meticulous hemostasis an important prerequisite in thyroid surgery for successful outcome. The mainstay for achieving hemostasis in thyroidectomy is tying and / or clipping of blood vessels. New technologies have been introduced , among them the vessel sealing device ( ligasure ) which seals vessels by fusing the inner layers of the vessel wall with minimal levels of thermal dispersion burning and tissue friction thereby reducing incidence of accidental burns . This study is designed to evaluate the safety and efficacy of using ligasure compared with conventional vessel ligation in open thyroid surgery

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • 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.

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

  • 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 ( group A)
Device: Ligasure
the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall
Active Comparator: Conventional vessel ligation (group B)
Procedure: Conventional vessel ligation
Conventional vessel ligation either tying and /or clipping of blood vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: Baseline

Measuring intraoperative blood loss using surgical towels and contents of suction.

Intraoperatively from skin incision " start of operation " to skin closure "complete the operation "
Baseline
Post-operative blood loss
Time Frame: From skin closure until one week post operatively
Measuring postoperative blood loss by measuring contents of drains
From skin closure until one week post operatively
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
Operation time
Time Frame: Baseline
From skin incision to skin closure
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Baseline up to two weeks

Measuring number of days of patient stay in hospital to be pain- free return to activity and work.

From day of surgery until discharge
Baseline up to two weeks

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hemostasis in 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.

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