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CompletedNCT05434715Updated Jun 28, 2022

Evaluation of Minimal Invasive Thyroidectomy

An interventional study of Thyroidectomy in Thyroid and Goiter, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-28.

Primary conditionGoiterRegistry: Thyroid DiseasesReclassifiedWhy we changed it
Registry
Thyroid Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Goiter
Why
  1. The study's listed conditions name Goiter, a narrower term within Thyroid Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Mar 2021, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Thyroid
  • Goiter

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03

In context

Goiter Reclassified

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 42 interventional studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Goiter, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 or suspicious for malignancy by Ultrasonography(US) or by Fine-Needle Aspiration Cytology (FNAC).
    4. Previous surgery or radiotherapy to the neck.
    5. Thyroiditis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureThyroidectomy

    removal of the thyroid gland

06

What researchers measure

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

    Time frame: 12 months

07

Study locations

1 site
  • Kafrelsheikh University
    Kafr Ash Shaykh, Kafr Al Sheikh 33516, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05434715
Responsible party
Ahmed Aouf (Dr, assistant lecturer of General Surgery, Kafrelsheikh University) — Principal investigator
First posted
Jun 28, 2022
Start date
Mar 1, 2021
Primary completion
May 1, 2022
Completion
Jun 10, 2022
Last update
Jun 28, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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