The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01906697

Enrollment

Registered

2013-07-24

Start date

2011-05-31

Completion date

2013-10-31

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyposis, Sinusitis

Brief summary

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

Detailed 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.

Interventions

PROCEDUREmiddle turbinate Radio Frequency (RF) turbinoplasty

middle turbinate Radio Frequency (RF) turbinoplasty

PROCEDUREmiddle turbinate resection

middle turbinate resection

PROCEDUREmiddle turbinate medialization

middle turbinate medialization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The Sino-Nasal Outcomes Test 22	three months after surgery	The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026