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Completed

NCT Number: NCT06310083

Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy

The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University Hospital of Assiut

Asyut, 17511, Egypt

About this study

The inferior turbinate (IT) plays a vital function in nose physiology by regulating the temperature and humidity of inhaled air and filtering foreign particles through the mucociliary clearance system.

One of the most common manifestations of chronic rhinitis is nasal obstruction. Nasal obstruction occurs as a result of submucosal or mucosal hypertrophy associated with increased vascularity of the inferior turbinate.

The location, size, and vasoactive capabilities of the inferior turbinate relegate it as a key player in airway resistance. Multiple pathologic processes may alter the gross and microscopic structure of the inferior turbinates, including septal deviation and inflammatory disorders such as allergic rhinitis, nonallergic rhinitis, and chronic rhinosinusitis. These disorders in turn lead to histological differences in terms of hypertrophy and hyperplasia, distorted cilia, inflammatory cell infiltrates, and mucosal thickening with subsequent macroscopic changes and symptomatic obstruction.

Surgical reduction of the inferior turbinate is warranted to relieve the nasal block caused by the hypertrophied inferior turbinates. Surgical reduction of the inferior turbinate involves removal of the mucosa, soft erectile tissue, and turbinate bone. Different techniques have been applied to increase the nasal airway passage, such as conventional turbinectomy, laser turbinectomy, cryoturbinectomy, electrocautery turbinectomy, conventional Turbinoplasty, microdebrider Turbinoplasty, coblation Turbinoplasty, radiofrequency Turbinoplasty, and ultrasound Turbinoplasty. Conventional turbinectomy (total or partial) is considered very effective in relieving nasal block. Due to the excessive loss of tissue (bone and mucosa), the postoperative complications include excessive bleeding requiring blood transfusion, crusting, pain, and prolonged recovery period. Hence, a more mucosal-friendly approach is preferred; the Turbinoplasty procedure, which resects either soft tissue or bone or both with preservation of the mucosa.

Conventional Turbinoplasty is designed to remove the nonfunctional obstructive part of the turbinate while preserving the functional medial mucosa, which plays the key role in the warming and humidification of air through the nasal passages. Performed endoscopically, inferior Turbinoplasty has the advantage over the other turbinate procedures by preserving sufficient mucosa, while removing adequate obstructed tissue to improve the airway significantly. The other term used for this technique is "submucosal resection", as a reference to its submucosal dissection procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients aged between 18 and 45 years complaining with a minimum 3-month duration of nasal obstruction combined with clinical findings of inferior turbinate hypertrophy

Exclusion criteria

  • Patient's Hemoglobin levels are less than 10gm%.
  • Patients who were Presented with acute upper respiratory tract infection.
  • Patients with other causes of nasal obstruction, e.g.,- allergic nasal polyposis, deviated nasal septum.
  • Patients who have nasal tumors.
  • Patients who had nasal operations before
  • Presence of bleeding disorder.
  • Presence of uncontrolled systemic disease.
  • During the period of menses

Treatment and study plan

Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy

Procedure

The study's Participants Were Randomly classified in two groups Interventional Group, applied for Submucosal Resection Turbinoplasty and the controlled group who were applied for Partial Inferior Turbinectomy

Primary outcomes

  1. Nasal Obstruction

    Time frame: 3 months

    questionnaire entitled Nasal Obstruction Syndrome Evaluation, known as NOSE score is used to evaluate the improvement in nasal obstruction This score has 5 questions about life quality. Each receives a score from 0 to 4 and these are summed up and multiplied by 20. The total NOSE score ranges from 0 to 100

  2. Nasal Discharge

    Time frame: 3 months

    rhinorrhea conventional visual analogue scale (VAS) is used to evaluate nasal Discharge. Patients were asked to rank their symptoms on a scale of 0-10, with 0 denoting no symptoms and 10 denoting the most severe symptoms, with mild symptoms scoring 0-3, moderate symptoms scoring 4-7, and severe symptoms scoring 8-10

  3. Crustations

    Time frame: 3 months

    an endoscopic score of "Lund and Kennedy" is used to evaluate postoperative Crustations Grade 0 Absence of crustations Grade 1 Mild crustations: partially filling the nasal cavity Grade 2 Severe crustations: fully filling the nasal cavity

Secondary outcomes

  1. intra operative blood loss

    Time frame: intraoperative

    Boezaart surgical field grading scale is used to evaluate intra-operative bleeding (primary), Grade 1 Minimal bleeding, no suction is needed Grade 2 Minimal bleeding, occasional suction is needed Grade 3 Slight bleeding, frequent suction is needed, and surgical field is threatened by bleeding a few seconds after removal of suction Grade 4 Bleeding is moderate, frequent suction is needed, and the surgical field is threatened by bleeding immediately after removal of suction Grade 5 Bleeding is severe, persistent suction is needed, and the surgical field is severely threatened by bleeding that cannot be controlled by suction

  2. Duration of operation (Minutes )

    Time frame: intraoperative

    Measurement the duration of operation by Minutes

  3. Hyposmia

    Time frame: 3 months

    percentage of patients whose Complaint ( Hyposmia ) Was improved postoperatively

Other outcomes

  1. Size Of Anterior part of Turbinate

    Time frame: Baseline ; 3 months

    Computed Tomography measurements of Anterior part of turbinate pre and postoperatively

  2. Size Of Posterior part of Turbinate

    Time frame: Baseline ; 3 months

    Computed Tomography measurements of posterior part of turbinate pre and postoperatively

  3. Space of Anterior nasal Cavity

    Time frame: Baseline ; 3 months

    Computed Tomography measurements of Anterior part of nasal Cavity pre and postoperatively

  4. Space of posterior nasal Cavity

    Time frame: Baseline ; 3 months

    Computed Tomography measurements of posterior part of nasal Cavity pre and postoperatively

Sponsors and collaborators

Lead sponsor

Ahmed Nabil Selim

Other

Registry information

Official study title

A Comparative Study of Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

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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