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临床试验/NCT02855931
NCT02855931已完成不适用

A Randomized Controlled Trial Comparing Partial Resection Versus Preservation of the Middle Turbinate in Surgery for Chronic Rhinosinusitis With Polyposis (CRSwP)

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年4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
入组人数
16
试验地点
1
主要终点
Change in the PeriOperative Sinus Endoscopy (POSE) score

研究概览

简要总结

Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal of surgery is now to widely marsupialize the sinus cavities in order to optimize topical steroid irrigation treatment in the postoperative period. With that being said, the true extent of surgery needed for optimal patient outcome has yet to be elucidated. More specifically, in the last 30 years, people have argued about the best way to manage the middle turbinate. Some state that it should be preserved at all times to protect the sinus cavities from inhaled irritants and allergens and keep this surgical landmark untouched for future surgeries. On the other hand, there are defenders of routine resection of this turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis, anosmia, or atrophic rhinitis but the more recent literature does not show such significant associations. A recent topic of debate is whether partial removal of the anterior and inferior portion of the middle turbinate affects nasal polyps recurrence or improves long-term outcomes by further facilitation of post-operative topical therapies. Some retrospective data has shown that its resection could prolong the time before the need for revision surgery and improve both endoscopic and olfaction scores. A few prospective studies have also been published but unfortunately none of these were randomized, thus introducing a significant selection bias. Thus, there is a need for a formal randomized, controlled trial to elucidate this question.

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
Single (Participant)

入排标准

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

入选标准

  • •Diagnosis of chronic rhinosinusitis with nasal polyposis
  • •Obtained consent for bilateral complete endoscopic sinus surgery (maxillary antrostomy, complete sphenoethmoidectomy and frontal recess surgery)
  • •Primary or revision surgery

排除标准

  • •Allergic fungal sinusitis
  • •Patients with previous surgery which included partial or complete middle turbinectomy, uni- or bilateral
  • •Pregnant or lactating women

研究组 & 干预措施

Middle turbinate preservation

No Intervention

Preservation of one middle turbinate

Middle turbinate resection

Experimental

Resection of one middle turbinate

干预措施: Middle turbinate resection (Procedure)

结局指标

主要结局

Change in the PeriOperative Sinus Endoscopy (POSE) score

时间窗: Postoperative evaluations at 1, 3 and 6 months

次要结局

未报告次要终点

研究者

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

Marie Bussières

Otolaryngologist - head and neck surgeon

Université de Sherbrooke

研究点 (1)

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