Evaluation of Minimal Invasive Thyroidectomy

• Sponsor: Kafrelsheikh University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05434715
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thyroid; Goiter	Procedure: Thyroidectomy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Minimal Invasive Thyroidectomy; A Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: May 1, 2022
• Actual Study Completion Date: Jun 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Thyroidectomy; removal of the thyroid gland
Active Comparator: 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.	Procedure: Thyroidectomy; removal of the thyroid gland

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kafrelsheikh University	Kafr Ash Shaykh	Kafr Al Sheikh	Egypt	33516

Sponsors and Collaborators

• Kafrelsheikh University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Aouf, Dr, assistant lecturer of General Surgery, Kafrelsheikh University
• ClinicalTrials.gov Identifier: NCT05434715
• Other Study ID Numbers: MKSU50-6-19
• First Posted: Jun 28, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Goiter

Study Results

No Results Posted as of Jun 28, 2022