Clinical Trials Logo
  1. Home
  2. Thyroidectomy
  3. NCT04186715
  4. Details
NCT04186715 Clinical Trial

Near Infrared Spectroscopy in Thyroidectomy

Thyroidectomy Clinical Trial

Official title:
The Effect of Vestibular Transoral Endoscopic Thyroidectomy on Cerebral Regional Oxygen Saturation: Comparison With Open Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04186715
Other study ID # AntalyaEAH01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2019
Est. completion date December 1, 2020

Study information
Verified date November 2019
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 1, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ASA I-II Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Near-infrared spectroscopy
The Near-infrared spectroscopy probes will be placed in the frontal region.

Locations
Country Name City State
Turkey University of Health Sciences, Antalya Training and Research Hospital Antalya

Sponsors (1)
Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02855866 - Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy N/A
Completed NCT05044351 - Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial N/A
Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
Completed NCT04082845 - Effect of Web-Based Training With Thyroidectomy Patients N/A
Not yet recruiting NCT02949856 - E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck N/A
Completed NCT02136459 - Non-neural Vocal Changes After Thyroidectomy N/A
Withdrawn NCT03060499 - Post Thyroidectomy Myocardial Function
Completed NCT03108742 - Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy N/A
Completed NCT03035383 - Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics N/A
Recruiting NCT06002984 - Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery N/A
Recruiting NCT06162390 - Optimal Concentration of Remifentanil for NIM Tube Intubation With Low-dose NMBA N/A
Recruiting NCT04481893 - Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy N/A
Completed NCT02577068 - Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy N/A
Completed NCT03349294 - Clinical Study of Biokinetic Model of Iodine-131 in Total(Near) Thyroidectomy Patients.
Recruiting NCT05851560 - Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid or Parathyroid Surgery Phase 1
Completed NCT02768753 - Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy N/A
Recruiting NCT05642741 - Validation of a Hypoparathyroidism Self-questionnaire
Withdrawn NCT02568085 - Trial Evaluating Use of Arista in Total Thyroidectomy N/A
Recruiting NCT01607242 - Impact of Total Thyroidectomy on Voice and Swallowing N/A
Completed NCT05681338 - Effect of the Coughing Technique During Subcutaneous Heparin Injection N/A