Sutureless Versus Conventional Thyroidectomy

February 3, 2019 updated by: Sameh Emile, Mansoura University

Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial

This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

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.

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:

  • Solitary thyroid nodule (STN)
  • Multinodular goiter
  • Controlled toxic goiter
  • Inflammatory goiter (thyroiditis)
  • Early-stage thyroid cancer.

Exclusion Criteria:

  • Patients unfit for surgery
  • patients unwilling to participate in the study
  • Pregnant women
  • Thyroid cancer with lymph node or distant metastasis.
  • Patients with psychiatric disturbances.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional thyroidectomy
Thyroidectomy with ligation and division of thyroid vessels
Procedure: Conventional thyroidectomy
Thyroid vessels are ligated with sutures and divided
Active Comparator: Harmonic scalpel thyroidectomy
Thyroidectomy with sealing of thyroid vessels using harmonic scalpel
Procedure: Harmonic scalpel thyroidectomy
Thyroid vessels are sealed using harmonic scalpel device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of postoperative drainage
Time Frame: At 24 hours after surgery
The volume of fluid drained in the suction drain placed in the neck in milliliters
At 24 hours after surgery

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Study Chair: Sabry Mahmoud, M.D., Mansoura 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 (Actual)

February 1, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

May 12, 2018

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 3, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mansoura62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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