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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Frontal Sinusitis

Treatments: Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation; Procedure: Functional Endoscopic Sinus Surgery; Device: Sinuplasty balloon; Device: Endoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02509663

6190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Sinuplasty balloon

Active Comparator group

Description:

Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty

Treatment:

Device: Sinuplasty balloon

Procedure: Functional Endoscopic Sinus Surgery

Conventional surgical procedure

Active Comparator group

Description:

Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation

Treatment:

Device: Endoscope

Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation