NCT05396703

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

September 6, 2023

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 11, 2022

Last Update Submit

September 5, 2023

Conditions

Thyroid Gland DiseaseSurgery

Keywords

TOETVANOTESSurgeryEndocrineThyroidCase Series

Outcome Measures

Primary Outcomes (3)

  • Complications initial

    Complications after performed surgery

    Immediately postoperative (during hospitalization)

  • 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)

  • 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.

Study Arms (1)

TOETVA

All patients who underwent a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center.

Procedure: TOETVA

Interventions

TOETVAPROCEDURE

Completed procedure.

TOETVA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach at the investigators' center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6419 PC, Netherlands

Location

Related Publications (1)

  • Kinet S, van Weezelenburg MAS, Pijnenburg A, Stoot JHMB, van Bastelaar J. Feasibility and complications after transoral endoscopic thyroidectomy via vestibular approach (TOETVA) - a single-center first experience case series. Langenbecks Arch Surg. 2024 May 15;409(1):158. doi: 10.1007/s00423-024-03347-3.

    PMID: 38748236DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Sam Kinet, MD

    Zuyderland MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 31, 2022

Study Start

October 22, 2019

Primary Completion

May 8, 2022

Study Completion

June 19, 2023

Last Updated

September 6, 2023

Record last verified: 2022-05

Locations

NL(1)