Near Infrared Spectroscopy in Thyroidectomy
The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy
1 other identifier
observational
40
1 country
1
Brief Summary
Thyroidectomy operations have traditionally been performed as open surgery. However, the scarring that occurs in the patient leads to cosmetic problems, especially in young women. Today, as a result of the development of minimally invasive surgical techniques, the number of natural orifice transluminal endoscopic surgeries (NOTES) is increasing. Surgical scars are avoided by using natural pathways such as the mouth, urethra, vagina or anus. Transoral endoscopic thyroidectomy (TOETVA) with vestibular approach, a form of NOTES, was first performed in 2011. In this method, the operation is performed through three ports entered near the gingiva-buccal sulcus. TOETVA surgeries are performed with an insufflation pressure of 6 mmHg in the neck region. No studies are examining the effects of this pressure on the blood vessels in the neck region on the blood supply to the brain tissue. Therefore, the investigators aim to compare cases operated using open thyroidectomy or TOETVA method by measuring cerebral regional tissue saturation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2019
CompletedFirst Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 16, 2021
November 1, 2019
1.1 years
November 26, 2019
February 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Before induction
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
10 minutes after induction
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
5 minutes after operation position
cerebral regional oxygen saturation in TOETVA
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
10 minutes after insufflation
cerebral regional oxygen saturation in TOETVA
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
10 minutes after desufflation
cerebral regional oxygen saturation in open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
10 minutes after platysma incision
cerebral regional oxygen saturation in open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
10 minutes after the closing of the platysma
cerebral regional oxygen saturation in TOETVA and open thyroidectomy
The values obtained from the right and left frontal region will be recorded through the near Infrared Spectroscopy probes.
Through operation completion, an average of 4 hours
Study Arms (2)
TOETVA
The demographic data of the patients undergoing TOETVA surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop.
Open thyroidectomy
The demographic data of the patients undergoing open thyroidectomy surgery will be recorded. Then, blood pressure, pulse pressure, pulse oximeter, end-tidal carbon dioxide, right and left cerebral regional oxygen values in the operation room will be recorded at certain intervals. It will also be recorded if complications develop.
Interventions
The Near-infrared spectroscopy probes will be placed in the frontal region.
Eligibility Criteria
Patients applying to our Institute for thyroidectomy.
You may qualify if:
- ASA I-II
You may not qualify if:
- Patients with neck surgery.
- Patients who received radiotherapy to the neck region.
- Patients with cerebrovascular or neurological disease.
- Patients who underwent open surgery during the operation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences, Antalya Training and Research Hospital
Antalya, 07100, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erhan OZYURT, MD
University of Health Sciences, Antalya Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2019
First Posted
December 5, 2019
Study Start
October 25, 2019
Primary Completion
November 25, 2020
Study Completion
December 1, 2020
Last Updated
February 16, 2021
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share