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Completed

NCT Number: NCT05434715

Evaluation of Minimal Invasive Thyroidectomy

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

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Key information

Conditions

Thyroid Endocrine System Diseases Goiter Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Thyroidectomy

Procedure

removal of the thyroid gland

Primary outcomes

  1. Degree of satisification of cosmetic appearance of the thyroidectomy scar

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Evaluation of Minimal Invasive Thyroidectomy; A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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