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临床试验/NCT07481045
NCT07481045已完成不适用

Effect of Concomitant Compensatory Inferior Turbinate Surgery on Functional Outcomes After Septorhinoplasty: A Randomized Controlled Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Change in Nasal Obstruction Symptom Evaluation (NOSE) score

研究概览

简要总结

Nasal obstruction is a common complaint among patients undergoing septorhinoplasty. In addition to septal deviation, compensatory inferior turbinate hypertrophy may contribute to impaired nasal airflow. For this reason, some surgeons routinely perform inferior turbinate reduction during septorhinoplasty. However, the necessity and functional benefit of this additional procedure remain controversial.

The aim of this randomized controlled study is to evaluate whether compensatory inferior turbinate surgery provides additional functional benefit when performed simultaneously with septorhinoplasty. Patients undergoing septorhinoplasty will be randomly assigned to either septorhinoplasty alone or septorhinoplasty combined with inferior turbinate surgery.

Functional outcomes will be assessed using both subjective and objective measures. Subjective nasal obstruction will be evaluated using the Nasal Obstruction Symptom Evaluation (NOSE) scale, and objective nasal airflow will be assessed using peak nasal inspiratory flow (PNIF). Patients will be followed for six months after surgery.

The results of this study are expected to clarify the role of compensatory inferior turbinate surgery in patients undergoing septorhinoplasty and provide evidence regarding whether routine turbinate intervention is necessary in this patient population.

详细描述

Nasal obstruction is a common complaint among patients with nasal septal deviation and is one of the major indications for septorhinoplasty. Although correction of septal deviation often improves nasal airflow, some patients present with compensatory inferior turbinate hypertrophy that may contribute to persistent nasal obstruction. For this reason, inferior turbinate surgery is frequently performed during septorhinoplasty. However, the additional functional benefit of routine turbinate intervention in these patients remains controversial.

This prospective randomized controlled study aims to evaluate the effect of compensatory inferior turbinate surgery on functional outcomes in patients undergoing septorhinoplasty. Patients with nasal obstruction due to septal deviation who are scheduled for septorhinoplasty will be enrolled and randomly assigned to one of two treatment groups: septorhinoplasty alone or septorhinoplasty combined with inferior turbinate surgery.

All surgical procedures will be performed using standard septorhinoplasty techniques. In the intervention group, inferior turbinate reduction will be performed during the same surgical session. Postoperative functional outcomes will be evaluated using both subjective and objective assessment tools. Subjective nasal obstruction will be assessed with the Nasal Obstruction Symptom Evaluation (NOSE) scale, and objective nasal airflow will be measured using peak nasal inspiratory flow (PNIF).

Patients will be followed for six months after surgery. Functional outcomes will be compared between the two groups to determine whether additional inferior turbinate surgery provides clinically meaningful improvement in nasal airway function when performed simultaneously with septorhinoplasty.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The investigator responsible for postoperative outcome assessment was blinded to the treatment allocation. Surgical procedures were performed by a single surgeon who was aware of the intervention. Participants were not blinded to the type of procedure performed.

入排标准

年龄范围
18 Years 至 53 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years
  • Patients presenting with nasal obstruction and aesthetic concerns requiring septorhinoplasty
  • Presence of nasal septal deviation confirmed by anterior rhinoscopy, nasal endoscopy, or computed tomography
  • Presence of compensatory inferior turbinate hypertrophy in the contralateral nasal cavity
  • Patients willing to participate and able to provide informed consent

排除标准

  • Previous nasal, septal, or turbinate surgery
  • Chronic rhinosinusitis with or without nasal polyps
  • Bilateral inferior turbinate hypertrophy
  • Absence of compensatory inferior turbinate hypertrophy
  • Patients requiring additional nasal procedures or grafting techniques beyond the standardized surgical protocol
  • Incomplete follow-up

研究组 & 干预措施

SRP

Experimental

Patients undergoing standard open functional septorhinoplasty without inferior turbinate intervention.

干预措施: Septorhinoplasty (Procedure)

SRP + CIT Surgery

Experimental

Patients undergoing septorhinoplasty combined with compensatory inferior turbinate surgery.

干预措施: Septorhinoplasty (Procedure)

SRP + CIT Surgery

Experimental

Patients undergoing septorhinoplasty combined with compensatory inferior turbinate surgery.

干预措施: Inferior Turbinate Surgery (Procedure)

结局指标

主要结局

Change in Nasal Obstruction Symptom Evaluation (NOSE) score

时间窗: Preoperative baseline and 6 months after surgery

The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated patient-reported questionnaire used to assess the severity of nasal obstruction. Scores range from 0 to 100, with higher scores indicating more severe nasal obstruction.

次要结局

  • Change in Peak Nasal Inspiratory Flow (PNIF)(Preoperative baseline and 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zülküf Küçüktağ

Principal Investigator

Saglik Bilimleri Universitesi

研究点 (1)

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