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临床试验/NCT03575689
NCT03575689已完成不适用

The Efficacy of Silastic Sheet Nasal Splints in Endoscopic Nasal Septal Repair Surgery: A Prospective Randomized Control Trial

St. Paul's Hospital, Canada4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年3月24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
130
试验地点
4
主要终点
Mladina

研究概览

简要总结

Septoplasty is one of the most performed surgeries in rhinology as a solo procedure, or in combination with sinus surgery. The procedure for septoplasty and postoperative management has evolved over time based on several studies that have been done. The current standard of care in our centre is to conduct a septoplasty using quilting technique and apply Doyle splints in both nostrils to stabilize the septum for 6 days. However these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty

详细描述

  1. Purpose

To compare the success rate of septoplasty in correcting the nasal septal deviation (with regards to nasal obstruction and intranasal access) among patient who used Doyle splints and those who did not. The investigators will also determine if patient's quality of life in the postoperative period is affected by the use of Doyle splints or not. 2. Hypothesis

Is there a significant difference in success rates of septoplasty in patients who used a Doyle nasal splint when compared with patients who did not use the Doyle nasal splint? Null hypothesis There is no significant difference in success rates of septoplasty in patients who used a Doyle nasal splint when compared with patients who did not use the Doyle nasal splint. 3. Justification

Currently in most North American rhinology clinics, nasal splints are used after septoplasty (using the quilting technique) to improve stability of the nasal septum. The quilting technique in addition to reduction of other complications was developed to improve septal stability after septoplasty. No study has been conducted to examine the efficacy of using only the quilting method when compared to the current standard of care which adds extra cost to the surgery. This study aims to evaluate the efficacy of the quilting technique in improving stability of the nasal septum among patients using nasal splints and those not on nasal splints after septoplasty.

A recent study (Objective usefulness of thin silastic septal splints after septal surgery; i Jung, M.D., Kim, M.D. et al Am J Rhinol Allergy 25, 182-185, 2011) has shown Insertion of a silastic septal splint after septal surgery should be accepted as a routine procedure. Our study is aiming to show that quilting suture in x-shaped fashion technique is as effective and safe as using them yet avoids the potential complication of discomfort/pain/toxic shock syndrome etc.

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 (Outcomes Assessor)

盲法说明

The PI will be the blinded assessor. The choice of which patient gets a Doyle splint will be randomized using the sealed envelope system mentioned above.

The randomization will be balanced to ensure that both arms have patients with extensive surgeries as well as isolated NSRs

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 19 years and above diagnosed with deviated nasal septum using the Mladina septal deviation scale who are complaining of nasal obstruction and/or sinus disease
  • These patients will also be undergoing a nasal septoplasty either as a standalone case or as part of endoscopic sinus surgery and/or resection of the inferior turbinates. These surgeries could either be a primary or revision case.

排除标准

  • Patients with sinonasal tumors
  • Cystic fibrosis or syndromic patients (e.g. Wegeners granulomatosis, immunocompromised)
  • Patients with autoimmune diseases
  • Patients who do not understand English language and to understand the purpose, methods and conduct of this study.

研究组 & 干预措施

Splint

Experimental

A. The Doyle splint will be places in both nostrils of the patient after septoplasty. The doyle splints will be removed 6 days after surgery as per standard of care. No other procedures will be changed during the surgery.

干预措施: Doyle Splint (Device)

No Splint

No Intervention

B. No Doyle splints will be placed in the nostrils of the patient after septoplasty. All standart of care visits will remain the same.

结局指标

主要结局

Mladina

时间窗: 3 months for every patient

Mladina Classification of Septal Deformity: This test will be performed by same blinded assessor before and after the surgery. This is a validated and widely used system for classifying nasal septal deviation.

次要结局

  • Visual Analog Scale(3 months for every patient)
  • Postoperative complications(3 months for every patient)

研究者

发起方
St. Paul's Hospital, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Javer

Director, St. Paul's Sinus Centre

St. Paul's Hospital, Canada

研究点 (4)

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