Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Cost-utility ratio
研究概览
简要总结
The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain, ensure faster return to daily life activities (reduction of the average length of hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and reduction of post-operative pain score seams decrease on EVA.
The economic impact of the sinuplasty balloon appears very favourable and fits into the strategy of development of the ambulatory practice.
详细描述
The primary objective is to estimate the cost-utility ratio of the sinuplasty balloon after frontal sinus surgery, compared to surgery by rigid instrumentation, in a randomized single-blind controlled study.
The secondary objectives is to compare:
- the two types of surgery
- the quality of life
- the feeling of pain in patients but also the occurrence of surgical times or complications between the two proposed techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman of age ≥ to 18 years.
- •Patient for which a frontal sinus surgery (Draf 1 type) is programmed for any type of frontal sinusitis unresponsive to drug treatment properly leads.
- •Patient affiliated to a social protection scheme Written informed consent of the patient
- •Signed informed consent
排除标准
- •Polyposis sinonasal or other sinus to be the subject of a simultaneous complementary intervention
- •Sinuso-nasal tumors
- •Osteogenesis
- •Fragile patients or patient needing gesture contraindicating surgery by rigid instrumentation
- •Contraindication with balloon using
- •Contraindication to general anesthesia
- •Immunosuppressive therapy
- •Patient under judicial protection
- •Pregnancy or Breastfeeding
- •Exclusion period determinated with concurrent participation in other experimental studies
- •Contrast medium allergy background
- •Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)
研究组 & 干预措施
Sinuplasty balloon
Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty
干预措施: Functional Endoscopic Sinus Surgery (Procedure)
Sinuplasty balloon
Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty
干预措施: Sinuplasty balloon (Device)
Conventional surgical procedure
Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation
干预措施: Functional Endoscopic Sinus Surgery using rigide instrumentation (Procedure)
Conventional surgical procedure
Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation
干预措施: Endoscope (Device)
结局指标
主要结局
Cost-utility ratio
时间窗: This ratio will be assessed for 12 months post surgery
Cost-utility ratio will be assessed with : * cost difference between sinuplasty balloon and conventional surgery * utility difference of these two surgery procedures estimated with EQ-5D questionnaire outcomes
次要结局
- Quality of the patient's life(This secondary outcome will be assessed for 12 month : at inclusion and at 1 Week , 3 weeks , 3 -6 and 12 months post surgery)
- Risks associated with intervention(This secondary outcome will be assessed for 12 month)
- Economic impact of the sinuplasty balloon(economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery)