Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy

March 12, 2024 updated by: Ahmed Nabil Selim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 17511
        • Al-Azhar University Hospital of Assiut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Submucosal Rescetion Turbinoplasty
participants in this group were applied for Endoscopic submucosal resection Turbinoplasty
Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy
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
Placebo Comparator: Partial Inferior Turbinectomy
participants in this group were applied for Partial Inferior Turbinectomy
Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative
Duration of operation (Minutes )
Time Frame: intraoperative
Measurement the duration of operation by Minutes
intraoperative
Hyposmia
Time Frame: 3 months
percentage of patients whose Complaint ( Hyposmia ) Was improved postoperatively
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size Of Anterior part of Turbinate
Time Frame: Baseline ; 3 months
Computed Tomography measurements of Anterior part of turbinate pre and postoperatively
Baseline ; 3 months
Size Of Posterior part of Turbinate
Time Frame: Baseline ; 3 months
Computed Tomography measurements of posterior part of turbinate pre and postoperatively
Baseline ; 3 months
Space of Anterior nasal Cavity
Time Frame: Baseline ; 3 months
Computed Tomography measurements of Anterior part of nasal Cavity pre and postoperatively
Baseline ; 3 months
Space of posterior nasal Cavity
Time Frame: Baseline ; 3 months
Computed Tomography measurements of posterior part of nasal Cavity pre and postoperatively
Baseline ; 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Nabil Selim

Investigators

  • Study Chair: Sabry H Easa, MD, Al-Azhar University Hospital of Assiut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMR for Turbinate Hypertrophy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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