Comparison of TOETVA and Conventional Thyroidectomy

NCT04647006 | Completed DMC

• 1 other identifier: Mehmet Taner Unlu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction-Objective: The application of transoral endoscopic thyroidectomy vestibular approach (TOETVA) is gradually increasing recently. However, it is not clear whether TOETVA is a true minimally invasive thyroidectomy compared to open conventional thyroidectomy. In this study, we aimed to evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response, pain and patient satisfaction. Material and Method: In this prospective study, 40 female patients between the ages of 18-65 were divided into 2 groups of 20 patients: TOETVA: 20 patients, open thyroidectomy: 20 patients. Operation time, inflammatory response with IL-6, white blood cell (WBC) and C-reactive protein (CRP), postoperative pain, postoperative complications and patient satisfaction were evaluated in both groups.

Conditions

Thyroid; Thyroid Nodule; Surgery

Keywords

thyroidectomy; transoral; TOETVA

Outcome Measures

Primary Outcomes (5)

• Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by CRP (C-reactive protein)

  To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; CRP (C-reactive protein) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.

  4 days

• Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by WBC (white blood cells)

  To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; WBC (white blood cells) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.

  4 days

• Evaluate the TOETVA and Open Conventional Thyroidectomy Techniques in Terms of Postoperative Inflammatory Response by IL-6 (Interleukin 6)

  To evaluate the TOETVA and open conventional thyroidectomy techniques in terms of postoperative inflammatory response; IL-6 (Interleukin 6) levels were measured in all patients for evaluating the inflammatory response at preoperative, postoperative second hour, first day and second day.

  4 days

• Evaluate the Postoperative Pain after TOETVA and Open Conventional Thyroidectomy Techniques Assessed by the Visual Analogue Scale

  Pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) score (0 to 10) on the 2nd and 12th hour, 1st and 2nd days postoperatively. Lower lip, lower chin and anterior neck area pain were evaluated separately with VAS score. VAS scores were determined by patients by marking the intensity of pain on the ruler, which was marked as 0 for the absence of pain and as 10 for the most severe pain sensation.

  4 days

• Comparison of Postoperative Patient Satisfaction Between Conventional Thyroidectomy and TOETVA

  Patient satisfaction was evaluated on postoperative 15th and 30th days in both groups. Patients were asked to evaluate and score the operation in general and in terms of cosmesis (1: bad and 4: very good). In addition, the patients were asked which surgery (TOETVA or conventional thyroidectomy) they would prefer if they would have the operation again.

  1 month

Study Arms (2)

Conventional Thyroidectomy

OTHER

Conventional Thyroidectomy

Procedure: thyroid

Transoral endoscopic thyroidectomy vestibular approach

ACTIVE COMPARATOR

Transoral endoscopic thyroidectomy vestibular approach

Procedure: thyroid

Interventions

thyroid PROCEDURE

Conventional Thyroidectomy and Transoral endoscopic thyroidectomy vestibular approach

Conventional Thyroidectomy; Transoral endoscopic thyroidectomy vestibular approach

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be aged 18 to 65 years
• Benign thyroid disease, with FNAB results Bethesda 3,4 or below 1 cm + Bethesda V, VI
• Thyroid volume less than 50 cm3
• Largest nodule diameter must be less than 4 cm
• No previous neck, chin and oral surgery
• No vocal cord paralysis for any reason
• In the preoperative period, clinically euthyroid and laboratory results in the euthyroid state
• Agreed to participate in the study were included in the study..

You may not qualify if:

• Patients with a FNAB result of Bethesda V, VI over 1 cm,
• Planning of central and/or lateral neck dissection due to thyroid cancer
• Patients with thyroid volume greater than 50 cm3
• Secondary intervention cases
• Patients with accompanying hyperparathyroidism
• Patients with preoperative vocal cord paralysis (VCP)
• Patients with ASA score III and IV
• Patients who were started with TOETVA and converted to the conventional method intraoperatively

Sponsors & Collaborators

• MUnlu: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (1)

Sisli Etfal Research Hospiatl

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Nodule

Interventions

Thyroid (USP)

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mehmet Uludag, 1

  Sisli Hamidiye Etfal Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: November 30, 2020
• Study Start: September 23, 2019
• Primary Completion: January 28, 2020
• Study Completion: March 30, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)