NCT04087447

Brief Summary

Voice plays a crucial role in human communication and function. Voice production is multidimensional, involving physiologic, biomechanical, and aerodynamic mechanisms that produce an acoustic output that is perceived by the auditory system. So its important to evaluate patients with voice disorders, whenever possible, to characterize the impact of the disorder(s) on all of the pertinent mechanisms/dimensions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 11, 2019

Last Update Submit

September 11, 2019

Conditions

Thyroidectomy

Outcome Measures

Primary Outcomes (2)

  • Assessment of voice function

    fibroptic endoscopic assessment of voice function

    from end of surgery till two months after surgery

  • Assessment of swallowing function

    fibroptic endoscopic assessment of swallowing function

    from end of surgery till two months after surgery

Secondary Outcomes (1)

  • postoperative care of these patients

    from end of surgery till two months after surgery

Study Arms (1)

Thyroidectomy group

patient undergoing thyroidectomy for simple nodular goiter

Procedure: Thyroidectomy

Interventions

ThyroidectomyPROCEDURE

Thyroidectomy

Thyroidectomy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults patients undergoing thyroid surgery

You may qualify if:

  • benign and malignant thyroid disease normal voice controlled thyroid hormones level

You may not qualify if:

  • Age below 18 years any cardiac, renal,hepatic, respiratory, mental can interfere with the surgery any voice changes due to any cause before surgery previous head and neck surgery neurological dysfunctions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Aya Sharkawy, MBBCH

CONTACT

01008137079Ayasharkawy20@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

September 12, 2019

Record last verified: 2019-09