The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

Phase 3

• Conditions: Nasal Polyposis; Sinusitis
• Interventions: Procedure: middle turbinate resection; Procedure: middle turbinate medialization; Procedure: middle turbinate Radio Frequency (RF) turbinoplasty

• Registration Number: NCT01906697
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2011-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	middle turbinate resection	middle turbinate resection
group C	middle turbinate medialization	middle turbinate medialization
group A	middle turbinate Radio Frequency (RF) turbinoplasty	middle turbinate Radio Frequency (RF) turbinoplasty

Primary Outcome Measures

Name	Time	Method
The Sino-Nasal Outcomes Test 22	one year 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.

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of