Evaluation of Minimal Invasive Thyroidectomy

Not Applicable

Completed

• Conditions: Goiter; Thyroid

• Registration Number: NCT05434715
• Lead Sponsor: Kafrelsheikh University

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-05-01
• Status Verified: 2022-06
• Study Completion: 2022-06-10
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of satisification of cosmetic appearance of the thyroidectomy scar	12 months	Degree of scar appearance satisification assessed by the patient and doctor using patient and observer scar assessment scale (POSAS) scale in both groups

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafr Al Sheikh, Egypt