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

Not Applicable

Terminated

• Conditions: Frontal Sinusitis
• Interventions: Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation; Procedure: Functional Endoscopic Sinus Surgery; Device: Endoscope; Device: Sinuplasty balloon

• Registration Number: NCT02509663
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-28
• Study Start: 2018-06-15
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional surgical procedure	Functional Endoscopic Sinus Surgery using rigide instrumentation	Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation
Sinuplasty balloon	Functional Endoscopic Sinus Surgery	Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty
Conventional surgical procedure	Endoscope	Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation
Sinuplasty balloon	Sinuplasty balloon	Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty

Primary Outcome Measures

Name	Time	Method
Cost-utility ratio	This ratio will be assessed for 12 months post surgery	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

Secondary Outcome Measures

Name	Time	Method
Quality of the patient's life	This secondary outcome will be assessed for 12 month : at inclusion and at 1 Week , 3 weeks , 3 -6 and 12 months post surgery	Patient's quality of life include the following exams : * EuroQoL EQ-5D Questionnaire; * SNOT-22 questionnaire
Risks associated with intervention	This secondary outcome will be assessed for 12 month	Risks associated with intervention include the following criteria : * Occurrence of surgical times; * Occurrence of complications; * Presence of opacification in the visible sinus CT
Economic impact of the sinuplasty balloon	economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery

Trial Locations

Locations (8)

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 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, France

Service ORL et de Chirurgie Cervico-Faciale; 🇫🇷 Nantes, France