The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Nasal Polyposis; Sinusitis

Treatments: Procedure: middle turbinate Radio Frequency (RF) turbinoplasty; Procedure: middle turbinate medialization; Procedure: middle turbinate resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01906697

92--02-48-6933

Details and patient eligibility

About

The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization

Full description

The management of middle turbinate in treatment of nasal polyposis is still an interesting debatable topic. The surgical access and its possible role in pathophysiology of sinusitis are two important points about its treatment. On the one hand, middle turbinate resection can improve surgical access and possibly reduce the nasal polyposis recurrence. On the other hand, there are some reports of anosmia, empty nose syndrome, synechia, and difficulties in revision surgery. Also, synechia, lateralization, and possibly recurrence can be the possible outcome after middle turbinate preservation.

Among different modalities, radiofrequency (RF) gradually increase its popularity as surgical tools, which can treat mucosal hypertrophy without any tissue removal. Inferior turbinate is a famous place for its usage, especially for decreasing of the nasal obstruction. Also, some authors have showed its effect on refractory allergic rhinitis, which is not only related to reducing of nasal obstruction, but also it is related to changing of the allergic mediators. [5, 6] Comparing to other treatments for turbinates is sparing its overlaid mucosa, which can reduce the possible future morbidities.

Probably considering of the above mention points, RF has a possible impact on the polypoid changes of middle turbinates and possibly does not have the same deleterious effect of the resection on cilia of mucosal layer. Therefore, we performed a randomized clinical trial to compare its outcome with two famous methods of the middle turbinate management: partial resection and medialization.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients with sinusitis who suffered from nasal polyposis which was resistant to maximal medical treatment (i.e. one puff of Fluticasone nasal spray twice daily plus amoxicillin clavulanic acid 625 mg tablet three times daily, for at least one month ).

Exclusion criteria

• floppy' change of the middle turbinate in the end of surgery.
• systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
• immune suppression,
• revision surgery,
• counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or
• any type of septoplasty indications are excluded from this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

group B

Active Comparator group

Description:

middle turbinate resection

Treatment:

Procedure: middle turbinate resection

group C

Active Comparator group

Description:

middle turbinate medialization

Treatment:

Procedure: middle turbinate medialization

group A

Active Comparator group

Description:

middle turbinate Radio Frequency (RF) turbinoplasty

Treatment:

Procedure: middle turbinate Radio Frequency (RF) turbinoplasty