Sutureless Versus Conventional Thyroidectomy

NCT ID: NCT03615456

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-12

Brief Summary

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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

Detailed Description

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Conditions

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Goiter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Conventional thyroidectomy

Thyroidectomy with ligation and division of thyroid vessels

Group Type ACTIVE_COMPARATOR

Conventional thyroidectomy

Intervention Type PROCEDURE

Thyroid vessels are ligated with sutures and divided

Harmonic scalpel thyroidectomy

Thyroidectomy with sealing of thyroid vessels using harmonic scalpel

Group Type ACTIVE_COMPARATOR

Harmonic scalpel thyroidectomy

Intervention Type PROCEDURE

Thyroid vessels are sealed using harmonic scalpel device

Interventions

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Conventional thyroidectomy

Thyroid vessels are ligated with sutures and divided

Intervention Type PROCEDURE

Harmonic scalpel thyroidectomy

Thyroid vessels are sealed using harmonic scalpel device

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Assistant professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabry Mahmoud, M.D.

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura62

Identifier Type: -

Identifier Source: org_study_id

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