Clinical trial NCT01906697: The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates
Official title: The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasal Polyposis
Sinusitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Sino-Nasal Outcomes Test 22
timeFrame: three months after surgery
measure: The Sino-Nasal Outcomes Test 22
timeFrame: 6 months after surgery
measure: The Sino-Nasal Outcomes Test 22
timeFrame: one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Babak Saedi, professor
role: PRINCIPAL_INVESTIGATOR
References: