TOETVA Feasibility and Complications - Single Center First Experience

September 5, 2023 updated by: Zuyderland Medisch Centrum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Zuyderland MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TOETVA
All patients who underwent a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center.
Procedure: TOETVA
Completed procedure.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Sam Kinet, MD, Zuyderland MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2019

Primary Completion (Actual)

May 8, 2022

Study Completion (Actual)

June 19, 2023

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWO Z2021024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymised patient sex, age, extent of resection, preoperative TSH values, TI-RADS classification, Bethesda classification, malignancy of lesion, and complications after surgery will be provided within the final manuscript.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on TOETVA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe