Sutureless Versus Conventional Thyroidectomy | NCT03615456

Studies
Sutureless Versus Conventional Thyroidectomy

NCT03615456

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Feb 5, 2019Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Goiter

Interventions

Conventional thyroidectomy
Harmonic scalpel thyroidectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

May 12, 2018Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Aug 2, 2018

First Posted Date

Aug 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2019

Last Update Posted Date

Feb 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Conventional thyroidectomy	Procedure	Thyroid vessels are ligated with sutures and divided	Conventional thyroidectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume of postoperative drainage	The volume of fluid drained in the suction drain placed in the neck in milliliters	At 24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sabry Mahmoud, M.D.	Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital		Al Mansurah	Dakahlia Governorate	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006042	Goiter

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided