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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02509663
First Posted: July 28, 2015
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose

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.


Condition Intervention
Frontal Sinusitis Procedure: Functional Endoscopic Sinus Surgery Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation Device: Sinuplasty balloon Device: Endoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: December 2015
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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...)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509663


Contacts
Contact: Christelle Back +33 3 88 11 60 08 christelle.back@chru-strasbourg.fr
Contact: anatta Razafimanantsoa + 33 3 88 11 54 14 anatta.razafimanantsoa@chru-strasbourg.fr

Locations
France
ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals Not yet recruiting
Strasbourg, France, 67000
Contact: Christian Debry    +33 3 88 12 76 44    christian.debry@chru-strasbourg.fr   
Contact: Jean Carvalho    +33 3 88 12 76 52    jean.carvalho@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christian Debry Strasbourg's University Hospitals
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02509663     History of Changes
Other Study ID Numbers: 6190
First Submitted: July 17, 2015
First Posted: July 28, 2015
Last Update Posted: November 26, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Sinusitis
Frontal Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases