Evaluation of Minimal Invasive Thyroidectomy

Thyroid Clinical Trial

Official title:

Evaluation of Minimal Invasive Thyroidectomy; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434715
• Other study ID #: MKSU50-6-19
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: June 2022
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 10, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Goiter
• Thyroid

Intervention

Procedure:
• Thyroidectomy
removal of the thyroid gland

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafr Al Sheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of satisification of cosmetic appearance of the thyroidectomy scar	Degree of scar appearance satisification assessed by the patient and doctor using patient and observer scar assessment scale (POSAS) scale in both groups	12 months