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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03615456
Other study ID # mansoura62
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date May 12, 2018

Study information

Verified date February 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 12, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional thyroidectomy
Thyroid vessels are ligated with sutures and divided
Harmonic scalpel thyroidectomy
Thyroid vessels are sealed using harmonic scalpel device

Locations

Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of postoperative drainage The volume of fluid drained in the suction drain placed in the neck in milliliters At 24 hours after surgery
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