跳至主要内容
临床试验/NCT04782596
NCT04782596已完成不适用

Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Changes in sino-nasal outcome test

研究概览

简要总结

The aim of the project is to compare the effect of different extent of resection of the posterior part of the septum on the postoperative nasal functions.

详细描述

The nasal cavity is used to heat, humidify and purify the air before entering other parts of the respiratory system. Other functions of the nose include in particular olfactory, immune, reflex or sexual functions.

Proper airflow through the nasal cavity is essential for all nasal functions; anatomical or flow changes can significantly affect nasal functions.

Endoscopic transnasal surgical approaches are modern, mini-invasive methods, enabling solution of pathologies in the area of the cranial base, through the nasal cavity. The advantage of this technique is absence of external incisions and scars and significantly better cosmetic effect, these methods also offer very good clarity and illumination of the operating field. Main disadvantage is risk of affecting functions of the nose.

To create a transnasal approach to skull base, it is necessary to perform lateralization of middle turbinates, resection of anterior wall of sphenoidal sinus and resection of posterior part of the nasal septum. These interventions are necessary for a good overview and manipulation in the operated area; however, they can lead to postoperative changes in the physiological functions of the nasal cavity, especially loss of smell, taste, altered airflow through the nasal cavity, mucociliary transport disorders, nasal obstruction, crusting or drying mucous membrane. All these adverse changes significantly affect patient's quality of life.

Larger extent of septal resection allows the surgeon to have a better overview and manoeuvrability in the operated area, which allows sufficient radicality and allows the solution of possible complications. On the other hand, greater resection also means greater interference with the anatomy of the nasal cavity and possible influence on nasal functions.

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
None

盲法说明

No masking will be used in the study.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • patients with functional pituitary adenoma indicating endoscopic transnasal extirpation of the pituitary adenoma

排除标准

  • patients after surgery of the nasal cavity or base of the skull
  • patients with nasal disease and PND
  • patients with olfactory disorders before surgery
  • patients with nasal septal deviation

结局指标

主要结局

Changes in sino-nasal outcome test

时间窗: 2 months

Sino-nasal outcome test will be used to assess postoperative changes in nasal function (using standardised SNOT 22 questionnaire)

Changes in nasal endoscopy

时间窗: 2 months

Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)

Changes in RhinoVAS questionnaire

时间窗: 2 months

RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)

次要结局

  • Changes in the quality of life(2 months)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验