Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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...)