TOETVA Feasibility and Complications - Single Center First Experience

Surgery Clinical Trial

Official title:

Feasibility and Complications After Transoral Endoscopic Thyroidectomy Via Vestibular Approach (TOETVA) - a Single-Center First Experience Case Series and Systematic Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396703
• Other study ID #: BWO Z2021024
• Status: Completed
• Start date: October 22, 2019
• Est. completion date: June 19, 2023

Study information

• Verified date: May 2022
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 19, 2023
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center

Exclusion Criteria:

• Patients who did not undergo (or will not undergo) a TOETVA at the investigators' center

Related Conditions & MeSH terms

• Surgery
• Thyroid Diseases
• Thyroid Gland Disease

Intervention

Procedure:
• TOETVA
Completed procedure.

Locations

Country	Name	City	State
Netherlands	Zuyderland MC	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications initial	Complications after performed surgery	Immediately postoperative (during hospitalization)
Primary	Complications before follow-up	Complications after performed surgery	If premature presentation occurs (admission after discharge and before follow-up consultation at 1 month after surgery)
Primary	Complications before follow-up	Complications after performed surgery	Data at first follow-up visit will be reported. First follow-up visit will be at (average) 1 month after discharge.