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临床试验/NCT07537920
NCT07537920已完成不适用

Comparison of the Outcome of Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Patients Undergoing Septoplasty

Shahida Islam Medical Complex1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月4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
发起方
入组人数
60
试验地点
1
主要终点
Mean post-operative pain

研究概览

简要总结

There is currently little data comparing intranasal silicone splinting versus trans-septal quilted suturing in terms of preventing problems following septoplasty. The purpose of this study is to compare the results of intranasal silicone splinting with trans-septal quilted suturing following septoplasty. After septoplasty, this study will give us a better procedure with fewer adverse effects. Based on the outcomes, this can then regularly be used that specific approach in general practice to treat these specific individuals in an effort to lower their morbidity

详细描述

With its essential physiological roles, the human nasal cavity has developed over millennia to warm, filter, and humidify breathed air while also promoting olfactory perception and immunological defense. Structural nasal obstruction can result from structural anomalies in the nasal cavity that alter airflow dynamics and raise nasal resistance. The ventilation, temperature control, and humidification processes of the nasal cavity are all negatively impacted by this disease. Numerous studies have demonstrated the positive results of septoplasty, a commonly used surgical procedure for a symptomatic deviated nasal septum. Notably, septoplasty is superior to nonsurgical therapy in reducing nasal obstruction in people with septal deviation, according to a randomized controlled trial.

Although the surgical techniques used in this surgery vary, the deviated cartilage and bony septum that provide a dead area between the mucosal flaps are usually removed. Although they are uncommon, post-operative problems such adhesions, perforation, and septal hematoma and the resulting abscess formation might happen. Three primary strategies have been used to avoid these issues. These include transseptal quilted suturing, intranasal silicon splinting, and intranasal occlusive packing. There is currently no evidence to support the use of intranasal occlusive packing because research has not shown that it affects the incidence of problems during septoplasty. For cartilage support, intranasal silicone splinting is quick, easy to perform, and technically straightforward. However, there is a chance of bacterial colonization and discomfort from frequent sneezing and epiphora. Quilting suture, on the other hand, is more widely accessible and better received by patients. Although it is more time-consuming and technically challenging, it can maintain the remaining cartilage and aid in the repair of mucosal tears.

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
10 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between the ages of 10 and 40 who are having septoplasty for a symptomatic nasal septum deviation identified by anterior rhinoscopy;

排除标准

  • Patients who have had nasal surgery in the past.
  • Individuals who suffer from bleeding disorders (INR >1.2).
  • Individuals with co-occurring disorders such as hypertension and diabetes mellitus (based on medical records and history).
  • Individuals with chronic liver disease, as determined by history and s/bilirubin levels greater than 1.0 mg/dl

研究组 & 干预措施

intranasal silicone splinting

Placebo Comparator

干预措施: intranasal silicone splinting (Procedure)

trans-septal quilting suturing

Experimental

干预措施: trans-septal quilting suturing (Procedure)

结局指标

主要结局

Mean post-operative pain

时间窗: 48 hours

The visual analogue sacle will measure it during the first week, with 0 denoting no discomfort and 10 denoting the worst pain

Rate of septal hematoma

时间窗: 4 weeks

A accumulation of blood between the cartilage and the bony nasal septum is known as a nasal septal hematoma, and it was considered positive if blood was seen when the needle was aspirated

次要结局

未报告次要终点

研究者

发起方
Shahida Islam Medical Complex
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Mudassar Saeed Pansota

Associate Professor

Shahida Islam Medical Complex

研究点 (1)

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