Frontal Sinusitis
Conditions
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.
Interventions
PROCEDUREFunctional Endoscopic Sinus Surgery
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.
PROCEDUREFunctional Endoscopic Sinus Surgery using rigide instrumentation
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.
DEVICESinuplasty balloon
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.
DEVICEEndoscope
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility ratio | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Patient's quality of life include the following exams : * EuroQoL EQ-5D Questionnaire * SNOT-22 questionnaire |
| Risks associated with intervention | This secondary outcome will be assessed for 12 month | Risks associated with intervention include the following criteria : * Occurrence of surgical times * Occurrence of complications * Presence of opacification in the visible sinus CT |
| Economic impact of the sinuplasty balloon | economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery | — |
Countries
France
Outcome results
None listed