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the manufacturer of the device has been bought and the new company does not want to continue the study anymore
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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinuplasty balloon | Active Comparator | Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty |
|
| Conventional surgical procedure | Active Comparator | Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Endoscopic Sinus Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility ratio | Cost-utility ratio will be assessed with :
| This ratio will be assessed for 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the patient's life | Patient's quality of life include the following exams :
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Debry | Strasbourg's University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin | Bordeaux | 33000 | France | |||
| Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil |
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|
| Functional Endoscopic Sinus Surgery using rigide instrumentation | Procedure | 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. |
|
| Sinuplasty balloon | Device | 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. |
|
| Endoscope | Device | 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. |
|
Risks associated with intervention include the following criteria :
|
| This secondary outcome will be assessed for 12 month |
| Economic impact of the sinuplasty balloon | economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery |
| Créteil |
| 94000 |
| France |
| Service ORL et de Chirurgie Cervico-Faciale | Nantes | 44000 | France |
| Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière | Paris | 75000 | France |
| Service ORL Institut Arthur Vernes | Paris | 75000 | France |
| Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie | Poitiers | 86000 | France |
| ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals | Strasbourg | 67000 | France |
| Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D015522 | Frontal Sinusitis |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019723 | Endoscopes |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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