NCT02509663

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frontal Sinusitis

Interventions

Type	Name	Description
PROCEDURE	Functional 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.
PROCEDURE	Functional 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.
DEVICE	Sinuplasty 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.
DEVICE	Endoscope	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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2015-07-28
• Last updated: 2020-03-09

Locations

8 sites across 1 country: France