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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Cost-utility ratio [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of the patient's life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: July 17, 2015
Date Started: December 2015
Date Completion:
Last Updated: November 25, 2015
Last Verified: July 2015