Evaluation of Minimal Invasive Thyroidectomy

NCT ID: NCT05434715

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-06-10

Brief Summary

The goals of minimally invasive approaches are better cosmetic results with small neck scar, decreasing postoperative pain, and shortening of hospital stay periods without postoperative complications.

The concept of surgical invasiveness cannot be limited to the length and site of the skin incision; it must be extended to all structures dissected during the procedure. Conventional thyroidectomy without raising subplatysmal flaps has proven to be effective in reducing postoperative pain and seroma

Detailed Description

Minimal invasive flapless thyroidectomy (MIFT) is a new technique that can be used in replacement of the conventional method of thyroidectomy for the management of selected cases of benign thyroid disorders.

This work aims to evaluate the feasibility, safety, and efficacy of Minimal Invasive Flapless Thyroidectomy (MIFT) in the management of thyroid disease as regards postoperative pain, cosmesis, operative time, and other postoperative complications in comparison to Conventional thyroidectomy technique.

Conditions

Thyroid; Goiter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

conventional technique of thyroidectomy

A standard transverse skin incision will be done two fingers above supra-sternal notch extend from the medial head of sternomastoid muscle at one side to the other one at the opposite side, incision of platysma along the whole length of skin incision.

Dissection of the thyroid gland will begin with securing the middle thyroid vein using ligation, bipolar diathermy, or harmonic scalpel.

Dissection of the upper pole with securing the superior thyroid vessel preserving the superior parathyroid glands and the external laryngeal nerve.

Severing the Berry's ligament with ligation of its artery and vein. The contralateral lobe of the thyroid gland will then be approached in a similar fashioon.

Group Type: ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type: PROCEDURE

removal of the thyroid gland

Minimal invasive technique

The procedure will start by placing a small incision 2.5-3cm at the upper border of the cricoid cartilage at one of the natural creases of the neck, followed by an incision of the platysma along the length of the skin incision.

Identification of the midline of the neck and division of the strap muscles, followed by dissection of the plane between the muscles and the anterior surface of the thyroid gland.

Dissection of the lateral surface of the thyroid lobe with identification Cutting of sternothyroid muscle at its superior portion. Individual ligaton of branches of superior thyroid artery and vein near to the gland using haemostatic techniques (Harmonic or LigaSure scalpel), guarding the superior parathyroid glands.

Appropriate dissection will then be done. Dissection of the inferior pole and vessel securing using Harmonic or LigaSure scalpel will take place, then dissection of the undersurface of the thyroid gland will be done to separate the gland from its bed.

Group Type: ACTIVE_COMPARATOR

Thyroidectomy

Intervention Type: PROCEDURE

removal of the thyroid gland

Interventions

Thyroidectomy

removal of the thyroid gland

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The limited size of the gland: volume less than 50 mm by ultrasound assessment. No evidence of retro-sternal extension. Benign nature of the disease proved by FNAC.

Exclusion Criteria

• the patients who have one or more of the following criteria:

1. The size of the gland is more than 50 mm by ultrasound assessment.

2. Patients with retro-sternal goitre.

3. Patients with proved malignancy or suspicious for malignancy by Ultrasonography(US) or by Fine-Needle Aspiration Cytology (FNAC).

4. Previous surgery or radiotherapy to the neck.

5. Thyroiditis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Aouf

Dr, assistant lecturer of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

Other Identifiers

MKSU50-6-19

Identifier Type: -

Identifier Source: org_study_id