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临床试验/NCT06687629
NCT06687629已完成不适用

Best Practice in the Management of Concha Bullosa in FESS Operation

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年3月21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
62
试验地点
1
主要终点
postoperative SNOT-22

研究概览

简要总结

Concha bullosa (CB) refers to the condition where the middle turbinate's interior is aerated (making the turbinate wide and thick). CB can narrow the middle meatus and the ostiomeatal complex. In adults suffering from chronic sinusitis, the prevalence of CB is approximately 34%. The most common treatment method for CB is turbinate crushing. This is considered a conservative treatment that preserves the mucous membranes relatively intact without opening the interior of the turbinate. Another fairly common method is the removal of the lateral part of the bullous middle turbinate. Opening the CB and removing the lateral part of the middle turbinate can lead to adhesions between the middle turbinate and the lateral wall of the nose. These adhesions can impede airflow and narrow or completely close the ostium or the surgically created middle meatal antrostomy. Crushing the CB is technically easier and possibly a less traumatic procedure. However, it is suspected that some of these crushed bullous turbinates may refill. The development of a mucocele is another potential issue. Crushing might be a better option compared to resection in the long term. Preserving the mucous membranes during crushing may reduce the formation of adhesions, which are sometimes seen after resection of the middle turbinate. The purpose of the study is to investigate the long-term benefits and side effects of CB treatment methods. The study will include 60 patients undergoing a basic Functional Endoscopic Sinus Surgery (FESS) procedure due to recurrent or chronic maxillary sinusitis. The patients will be randomized, with 31 undergoing resection and 31 undergoing crushing. Before the procedure, patients will undergo a CT scan (NSO-TT) and symptom evaluation through various questionnaires. All patients will also undergo nasoscopy.

One year after the procedure, the patients' conditions will be reassessed (questionnaires, nasoscopy, NSO-TT only if necessary), including the need for revision surgery.

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

入排标准

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

入选标准

  • chronic or recurrent rhinosinusitis
  • 3 months of regular nasal corticosteroid usage
  • No prior endoscopic procedures of the paranasal sinuses
  • EPOS criteria for CRS are met: inflammation of the paranasal sinuses with at least 2 symptoms, one of which must be nasal obstruction/congestion or nasal discharge (anterior/posterior):
  • facial pain/pressure in the facial area
  • reduced or lost sense of smell SNOT-22 25 or higher
  • Complications of CRS (e.g., mucocele)
  • Pregnancy/breastfeeding or plans for them in the near future
  • Coagulation disorders
  • Systemic diseases: cystic fibrosis, primary ciliary dysfunction, sarcoidosis, Wegener's granulomatosis
  • Immunosuppression: diagnosed SAD, CVI, HIV, or use of biological/immunosuppressive drugs
  • Immunotherapy
  • Daily use of systemic corticosteroids
  • Communication issues (non-Finnish-speaking patient, neurological/psychiatric problems)
  • SNOT-22 score < 25

排除标准

  • 未提供

研究组 & 干预措施

crushing

Active Comparator

Concha bullosa crushing group

干预措施: Concha bullosa crushing (Procedure)

resection

Active Comparator

Concha bullosa resection group

干预措施: Concha bullosa resection (Procedure)

结局指标

主要结局

postoperative SNOT-22

时间窗: 1 year

postoperative SNOT-22 score

次要结局

  • LM endoscopy score(1 year)

研究者

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

Mario Järvekülg

specialist doctor

Helsinki University Central Hospital

研究点 (1)

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