NCT04329455

Brief Summary

Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 30, 2020

Last Update Submit

March 30, 2020

Conditions

Safety and Cosmetic Issues in Endoscopic Thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Safety of Endoscopic Thyroidectomy

    2020_2023

Secondary Outcomes (1)

  • Cosmetic outcome of Endoscopic Thyroidectomy

    2020_2023

Study Arms (1)

Intervention group

Procedure: Endoscopic thyroidectomy

Interventions

Endoscopic thyroidectomyPROCEDURE

Endoscopic thyroidectomy in Thyroid Nodules

Intervention group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

30 patients age group 18\_55 years with unilateral or bilateral thyroid nodules benign according to preoperative FNAC and normal thyroid function

You may qualify if:

  • benign thyroid nodules unilateral or bilateral Normal thyroid function

You may not qualify if:

  • malignant Thyroid Nodules Recurrent goitre Toxic goitre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Gamal

Asyut, 71111, Egypt

RECRUITING

Central Study Contacts

Ahmed Mohamed Gamal, MD

CONTACT

01069850499ahmedgamalgeneralsurgery@gmail.com

Ahmed Mohamed Gamal

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)