NCT03615456

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

July 30, 2018

Last Update Submit

February 3, 2019

Conditions

Goiter

Outcome Measures

Primary Outcomes (1)

  • Volume of postoperative drainage

    The volume of fluid drained in the suction drain placed in the neck in milliliters

    At 24 hours after surgery

Study Arms (2)

Conventional thyroidectomy

ACTIVE COMPARATOR

Thyroidectomy with ligation and division of thyroid vessels

Procedure: Conventional thyroidectomy

Harmonic scalpel thyroidectomy

ACTIVE COMPARATOR

Thyroidectomy with sealing of thyroid vessels using harmonic scalpel

Procedure: Harmonic scalpel thyroidectomy

Interventions

Conventional thyroidectomyPROCEDURE

Thyroid vessels are ligated with sutures and divided

Conventional thyroidectomy
Harmonic scalpel thyroidectomyPROCEDURE

Thyroid vessels are sealed using harmonic scalpel device

Harmonic scalpel thyroidectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Sabry Mahmoud, M.D.

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of surgery

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

February 1, 2017

Primary Completion

February 28, 2018

Study Completion

May 12, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)