Back to resultsSutureless Versus Conventional Thyroidectomy
Primary Purpose
Goiter
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional thyroidectomy
Harmonic scalpel thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Goiter
Eligibility 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.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional thyroidectomy
Harmonic scalpel thyroidectomy
Arm Description
Thyroidectomy with ligation and division of thyroid vessels
Thyroidectomy with sealing of thyroid vessels using harmonic scalpel
Outcomes
Primary Outcome Measures
Volume of postoperative drainage
The volume of fluid drained in the suction drain placed in the neck in milliliters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03615456
Brief Title
Sutureless Versus Conventional Thyroidectomy
Official Title
Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
May 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional thyroidectomy
Arm Type
Active Comparator
Arm Description
Thyroidectomy with ligation and division of thyroid vessels
Arm Title
Harmonic scalpel thyroidectomy
Arm Type
Active Comparator
Arm Description
Thyroidectomy with sealing of thyroid vessels using harmonic scalpel
Intervention Type
Procedure
Intervention Name(s)
Conventional thyroidectomy
Intervention Description
Thyroid vessels are ligated with sutures and divided
Intervention Type
Procedure
Intervention Name(s)
Harmonic scalpel thyroidectomy
Intervention Description
Thyroid vessels are sealed using harmonic scalpel device
Primary Outcome Measure Information:
Title
Volume of postoperative drainage
Description
The volume of fluid drained in the suction drain placed in the neck in milliliters
Time Frame
At 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabry Mahmoud, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Sutureless Versus Conventional Thyroidectomy
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