Evaluation of Minimal Invasive Thyroidectomy

NCT05434715 | Completed

• 1 other identifier: MKSU50-6-19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid; Goiter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conventional technique of thyroidectomy

ACTIVE COMPARATOR

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

Minimal invasive technique

ACTIVE COMPARATOR

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

Interventions

Thyroidectomy PROCEDURE

removal of the thyroid gland

Minimal invasive technique; conventional technique of thyroidectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• the patients who have one or more of the following criteria:
• The size of the gland is more than 50 mm by ultrasound assessment.
• Patients with retro-sternal goitre.
• Patients with proved malignancy or suspicious for malignancy by Ultrasonography(US) or by Fine-Needle Aspiration Cytology (FNAC).
• Previous surgery or radiotherapy to the neck.
• Thyroiditis.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Thyroid Diseases; Goiter

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, assistant lecturer of General Surgery

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 28, 2022
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 10, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

EG (1)