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Sutureless Versus Conventional Thyroidectomy

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ClinicalTrials.gov Identifier: NCT03615456
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Goiter Procedure: Conventional thyroidectomy Procedure: Harmonic scalpel thyroidectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : May 12, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615456


Locations
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Egypt
Mansoura university hospital
Mansourah, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Sabry Mahmoud, M.D. Mansoura University
More Information
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Responsible Party: Sameh Emile, Assistant professor of surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03615456    
Other Study ID Numbers: mansoura62
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Goiter
Thyroid Diseases
Endocrine System Diseases