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

Frontal Sinusitis Clinical Trial

— SIBA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02509663
• Other study ID #: 6190
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Frontal Sinusitis
• Sinusitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin	Bordeaux
France	Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil	Créteil
France	Service ORL et de Chirurgie Cervico-Faciale	Nantes
France	Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière	Paris
France	Service ORL Institut Arthur Vernes	Paris
France	Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie	Poitiers
France	ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals	Strasbourg
France	Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Economic impact of the sinuplasty balloon		economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery