Near Infrared Spectroscopy in Thyroidectomy

NCT ID: NCT04186715

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-25

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroidectomy Near-infrared Spectroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Near-infrared spectroscopy

Intervention Type DEVICE

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

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.

Near-infrared spectroscopy

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Near-infrared spectroscopy

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erhan OZYURT, MD

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Antalya Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences, Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AntalyaEAH01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Virtual Reality Applications
NCT06792929 NOT_YET_RECRUITING NA
New Intraoperative Nerve Monitoring Device
NCT07071571 NOT_YET_RECRUITING NA