Frontal Sinusitis Clinical Trial
Official title:
Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02981017 -
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
|
N/A |