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

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

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.

Study Overview

• Status: Terminated
• Conditions: Frontal Sinusitis
• Intervention / Treatment: Procedure: Functional Endoscopic Sinus Surgery; Device: Sinuplasty balloon; Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation; Device: Endoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
  • Créteil, France, 94000
    • Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
  • Nantes, France, 44000
    • Service ORL et de Chirurgie Cervico-Faciale
  • Paris, France, 75000
    • Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
  • Paris, France, 75000
    • Service ORL Institut Arthur Vernes
  • Poitiers, France, 86000
    • Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
  • Strasbourg, France, 67000
    • ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
  • Toulouse, France, 31000
    • Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sinuplasty balloon; Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty	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.; 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.
Active Comparator: Conventional surgical procedure; Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation	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: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christian Debry, Strasbourg's University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Frontal Sinusitis
• Other Study ID Numbers: 6190

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No