Clinical trial NCT02509663: Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons
Official title: Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frontal Sinusitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2015-07-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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...)

Primary outcomes:
measure: Cost-utility ratio
timeFrame: This ratio will be assessed for 12 months post surgery
Secondary outcomes:
measure: Quality of the patient's life
timeFrame: This secondary outcome will be assessed for 12 month : at inclusion and at 1 Week , 3 weeks , 3 -6 and 12 months post surgery
measure: Risks associated with intervention
timeFrame: This secondary outcome will be assessed for 12 month
measure: Economic impact of the sinuplasty balloon
timeFrame: economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
city: Créteil
country: France
facility: Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
city: Nantes
country: France
facility: Service ORL et de Chirurgie Cervico-Faciale
city: Paris
country: France
facility: Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
city: Paris
country: France
facility: Service ORL Institut Arthur Vernes
city: Poitiers
country: France
facility: Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
city: Strasbourg
country: France
facility: ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
city: Toulouse
country: France
facility: Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey
Study officials:
affiliation: Strasbourg's University Hospitals
name: Christian Debry
role: PRINCIPAL_INVESTIGATOR
References: