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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
9
Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.
FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy. The procedure works by cutting to remove bone and tissue to enlarge the sinus opening.
Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.
FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy. The procedure works by cutting to remove bone and tissue to enlarge the sinus opening.
Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
Bordeaux, France
Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
Créteil, France
Service ORL et de Chirurgie Cervico-Faciale
Nantes, France
Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
Paris, France
Service ORL Institut Arthur Vernes
Paris, France
Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
Poitiers, France
ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
Strasbourg, France
Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey
Toulouse, France
Cost-utility ratio
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
Time frame: This ratio will be assessed for 12 months post surgery
Quality of the patient's life
Patient's quality of life include the following exams : * EuroQoL EQ-5D Questionnaire * SNOT-22 questionnaire
Time frame: 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
Risks associated with intervention include the following criteria : * Occurrence of surgical times * Occurrence of complications * Presence of opacification in the visible sinus CT
Time frame: This secondary outcome will be assessed for 12 month
Economic impact of the sinuplasty balloon
Time frame: economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery
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