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临床试验/NCT06920368
NCT06920368招募中不适用

Comparative Study Between the Efficacy of Trans-Septal Quilting Sutures, Nasal Pack and Intranasal Silicon Splint in Endoscopic Septoplasty

Tanta University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5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
招募中
入组人数
90
试验地点
1
主要终点
post operative pain

研究概览

简要总结

the aim of the study is to compare complication of trans-nasal quilting sutures, nasal pack and intra intranasal silicon splint in endoscopic septoplasty

详细描述

Septoplasty is the recommended procedure for treating deviated septum and many surgeons are adopting an increasingly conservative approach to septal surgery, such that only the deviated portion of the septum is addressed by the surgery.

The surgical methods utilized in this procedure differ, though the procedure typically involves removal of the deviated cartilage and bony septum that creates a dead space between the mucosal flaps. Although rare, complications such as septal hematoma and consequently abscess formation, adhesions and perforation can occur post-operatively. Three main methods have been employed to prevent such complications. These are intranasal occlusive packing, intranasal silicon splinting, and trans-septal quilting suturing.

However, the totally occlusive nasal packing has many temporary negative effects on the patients' quality of life, which are well studied in the literature. The main disadvantages include: sleep disturbance, patient's discomfort, local pain, headache, dysphagia, breathing difficulty, anxiety and more severe pain on pack removal(6). Bilateral nasal packing may affect the respiratory function due to inadequate oral breathing causing nocturnal hypoxia, which may become more apparent in patients with obstructive sleep apnea or chronic lung diseases. Eustachian tube dysfunction, intranasal infections, toxic shock syndrome, laryngeal or bronchial spasm, myocardial infarction, cerebrovascular accidents has been reported. In addition, the mucosal damage caused by nasal packing may lead to loss of cilia and affects the mucociliary clearance during the healing period.

Intranasal silicone splinting is fast, technically simple and can be used for cartilage support. However, it can cause discomfort in terms of frequent sneezing and epiphora and has a potential risk for bacterial colonization.

The most important advantages of the suture technique include: the non-obliteration of the nasal cavities and the absence of agony associated with pack removal, so it highly decreases patient's discomfort and anxiety related to breathing and pack removal.

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
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Healthy adult patient of different ages from 16 to 60 year-old with symptomatic deviated nasal septum

排除标准

  • •Patient with nasal polyposis or nasal tumors or patients with sinusitis not responding to medical treatment.
  • •Patient with previous septal operation
  • •Patient who is planned to do partial inferior turbinectomy or turbinoplasty with septoplasty
  • •Patients with contraindications for general surgery

研究组 & 干预措施

nasal pack

Active Comparator

pack is put after septoplasty operation for prevention of complication of septoplasty

干预措施: septoplasty with nasal packs (Procedure)

intra-nasal silicon splint

Active Comparator

intra-nasal silicon splint is put after septoplasty operation for prevention of complication of septoplasty

干预措施: septoplasty with intra-nasal silicon splint (Procedure)

trans-septal quilting sutures

Active Comparator

trans-septal quilting sutures after septoplasty operation for prevention of complication of septoplasty

干预措施: septoplasty with trans--septal quilting sutures (Procedure)

结局指标

主要结局

post operative pain

时间窗: 1 week, 1 month and 3 months postoperatively

post operative pain will be assessed via Visual Analogue scale ( VAS ) on scale from 0 to 10 as higher scores mean worse outcome.

complication of septoplasty

时间窗: 1 week, one month and 3 months postoperatively

endoscopic assessment of post operative recovery and complication

improvement of nasal symptoms

时间窗: 1 week, 1 months and 3 months post operatively

improvement of nasal symptoms will be assessed by using validated Arabic version of NOSE score from 0 to 4 as higher scores mean worse outcome.

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

Ahmed Yahia Ibrahim Ata

principal invistigator

Tanta University

研究点 (1)

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