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临床试验/NCT06310083
NCT06310083已完成不适用

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

Ahmed Nabil Selim1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Nasal Obstruction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The surgeons performed the nasal surgery and evaluating postoperative measurable outcomes was blinded about cases who were subjected to Endoscopic submucosal resection Turbinoplasty

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Submucosal Rescetion Turbinoplasty

Active Comparator

participants in this group were applied for Endoscopic submucosal resection Turbinoplasty

干预措施: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy (Procedure)

Partial Inferior Turbinectomy

Placebo Comparator

participants in this group were applied for Partial Inferior Turbinectomy

干预措施: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy (Procedure)

结局指标

主要结局

Nasal Obstruction

时间窗: 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

Crustations

时间窗: 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

Nasal Discharge

时间窗: 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

次要结局

  • intra operative blood loss(intraoperative)
  • Duration of operation (Minutes )(intraoperative)
  • Hyposmia(3 months)

研究者

发起方
Ahmed Nabil Selim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Nabil Selim

Lecturer of otorhinolaryngology

Al-Azhar University

研究点 (1)

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