Clinical trial NCT06310083: Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy
Official title: A Comparative Study of Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Turbinate; Hypertrophy Mucous Membrane
Keywords: turbinoplasty
Turbinectomy
Turbinate Hypertrophy
Endoscopy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group.

Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty.

Group B (control group): Who applied for partial inferior turbinectomy.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nasal Obstruction
timeFrame: 3 months
measure: Nasal Discharge
timeFrame: 3 months
measure: Crustations
timeFrame: 3 months
Secondary outcomes:
measure: intra operative blood loss
timeFrame: intraoperative
measure: Duration of operation (Minutes )
timeFrame: intraoperative
measure: Hyposmia
timeFrame: 3 months
Other outcomes:
measure: Size Of Anterior part of Turbinate
timeFrame: Baseline ; 3 months
measure: Size Of Posterior part of Turbinate
timeFrame: Baseline ; 3 months
measure: Space of Anterior nasal Cavity
timeFrame: Baseline ; 3 months
measure: Space of posterior nasal Cavity
timeFrame: Baseline ; 3 months
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University Hospital of Assiut
Study officials:
affiliation: Al-Azhar University Hospital of Assiut
name: Sabry H Easa, MD
role: STUDY_CHAIR
References:
citation: Al Awad, M. K., & Ali, M. Y. (2022). Inferior Turbinate Hypertrophy Histopathology in Allergic Rhinitis Patients and in Patients with Deviated Nasal Septum. Egyptian Journal of Ear, Nose, Throat and Allied Sciences, 23(23). https://doi.org/10.21608/ejentas.2022.141170.1518
citation: Abdullah B, Singh S. Surgical Interventions for Inferior Turbinate Hypertrophy: A Comprehensive Review of Current Techniques and Technologies. Int J Environ Res Public Health. 2021 Mar 26;18(7):3441. doi: 10.3390/ijerph18073441.
citation: Thamboo, A., Ayoub, N., Maul, X., & Nayak, J. (2021a). The Inferior Turbinate: Role in Normal Respiration and Airway Obstruction. In Current Otorhinolaryngology Reports (Vol. 9, Issue 4, 98 pp. 383-388). Springer Science and Business Media B.V. https://doi.org/10.1007/s40136-021- 00370-6
citation: Lee KC, Cho JM, Kim SK, Lim KR, Lee SY, Park SS. The Efficacy of Coblator in Turbinoplasty. Arch Craniofac Surg. 2017 Jun;18(2):82-88. doi: 10.7181/acfs.2017.18.2.82. Epub 2017 Jun 26.
citation: Elshipli NA, El-Sisi HE, El-Fattah AMA, Al-Saddeik MAE. Outcome comparison of submucous resection versus combined submucous diathermy and outfracture for treatment of inferior turbinate hypertrophy. Eur Arch Otorhinolaryngol. 2021 Oct;278(10):3827-3837. doi: 10.1007/s00405-021-06663-2. Epub 2021 Feb 13.
citation: Thirugnanamani, R., Sahadevan, S., Ramabhadraiah, A. K., Menon P, A., & M Prabhu, R. (2021). Benefits of Turbinectomy vs Turbinoplasty - A Prospective Study. Bengal Journal of Otolaryngology and Head Neck Surgery, 29(2). https://doi.org/10.47210/bjohns.2021.v29i2.435
citation: Amhimmid, R. H., Mohamed, W., Amin, B., Mohamed, A. M., & Odabasha, A. E. (2022). Endoscopic Inferior Turbinoplasty Versus Radiofrequency Ablation for Treatment of Inferior Turbinate Hypertrophy. In The Egyptian Journal of Hospital Medicine (Vol. 88). https://ejhm.journals.ekb.eg/
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