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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial

Conditions
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Frontal Sinusitis

Intervention / Treatment
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* Procedure: Functional Endoscopic Sinus Surgery
* Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation
* Device: Sinuplasty balloon
* Device: Endoscope


Participation Criteria
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Eligibility Criteria
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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...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sinuplasty balloon<br>Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty | Procedure: Functional Endoscopic Sinus Surgery<br>* 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.<br>Device: Sinuplasty balloon<br>* 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.<br>|
| Active Comparator: Conventional surgical procedure<br>Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation | Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation<br>* 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.<br>Device: Endoscope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This ratio will be assessed for 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the patient's life | Patient's quality of life include the following exams : EuroQoL EQ-5D Questionnaire SNOT-22 questionnaire | 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 | 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 |