The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04842942
Collaborator
(none)
15
1
1
31
0.5

Study Details

Study Description

Brief Summary

This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TOETVA
Phase 1

Detailed Description

Type of Study This is a single center, prospective case series

Sample Size Since this is a feasibility study we will first include 15 patients. If we find the TOETVA a safe and feasible approach, we will perform the same study in more patients using the results of this study for a power size calculation.

Study Population Patients (> 18 years) undergoing (para)thyroid surgery for the indication of a benign or indeterminate thyroid nodule, well differentiated papillary thyroid carcinoma, well-controlled Grave's disease or a parathyroid adenoma.

Study Design This is a single center, prospective case series designed to assess the safety and feasibility of TOETVA in a small cohort of patients at University Health Network Toronto. Included patients will undergo a TOETVA-procedure in stead of the standard open surgical procedure.

Study Intervention The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.

Primary Objective The study objective is to assess the safety and feasibility of this procedure in a small cohort of patients at University Health Network Toronto, Ontario.

Endpoints of the study The main study endpoints consist of

  1. Surgical Outcomes: rate of post-operative recurrent laryngeal nerve palsy, rate of post-operative hypocalcemia, and rate of neck incision (conversion to open), oral infections, neck infection, hematoma, seroma, subcutaneous emphysema, gas-induced embolism, surgical time, and length of stay.

  2. Quality of Life - EORTC Thyroid specific Health related quality of life

These endpoints will be compared to historical age/indication controls for analysis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.The study intervention in this study is the TOETVA-procedure. This is an Transoral Endoscopic Thyroidectomy Vestibular Approach.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Safety and Feasibility of Transoral Endoscopic Thyroidectomy Vestibular Approach
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TOETVA

Transoral Endoscopic Thyroidectomy Vestibular Approach

Procedure: TOETVA
Transoral Endoscopic Thyroidectomy Vestibular Approach

Outcome Measures

Primary Outcome Measures

  1. Post-operative recurrent laryngeal nerve palsy [12 months]

    Number of participants with post-operative recurrent laryngeal nerve palsy

  2. Postoperative hypocalcemia [12 months]

    Number of participants with postoperative hypocalcemia

  3. Neck incision [1 month]

    Number of conversions to open

  4. Rate of oral infections [12 months]

    Number of participants with oral infections

  5. Rate of hematoma [1 month]

    Number of participants with hematomas

  6. Rate of seroma [1 month]

    Number of participants with seromas

  7. Rate of neck infection [12 months]

    Number of participants with neck infections

  8. Rate of subcutaneous emphysema [12 months]

    Number of participants with subcutaneous emphysema

  9. Rate of gas-induced embolism [12 months]

    Number of participants with gas-induced embolism

  10. Surgical time [until surgical discharge, average of 24 hours]

    Surgical time in hours

  11. Length of stay [until surgical discharge, average of 24 hours]

    Length of stay in days

Secondary Outcome Measures

  1. Quality of Life Score [12 months]

    EORTC Thyroid specific Health related quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma.

  • Total thyroid size is 7-8 cm (no more than 10 cm)

  • Their age is ≥18 years and ≤80 years

  • Able to give written consent

Exclusion Criteria:
    • History of neck surgery or neck radiotherapy
  • Recurrent thyroid disease

  • Lymph node metastases

  • Presence of intraoral infections

  • Presence of extrathyroidal or substernal extensions

  • Smoking

  • Morbid obesity

  • Contra-indication to general anesthesia with nasotracheal intubation

  • Previous mediastinal surgery

  • Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle)

  • Any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univeristy Health Network Toronto Ontario Canada M5G2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Jesse D Pasternak, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04842942
Other Study ID Numbers:
  • 19-5679
First Posted:
Apr 13, 2021
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2021