Overview

This trial is active, not recruiting.

Conditions nasal polyposis, sinusitis
Treatments middle turbinate radio frequency (rf) turbinoplasty, middle turbinate resection, middle turbinate medialization
Phase phase 3
Sponsor Tehran University of Medical Sciences
Start date May 2011
End date September 2013
Trial size 90 participants
Trial identifier NCT01906697, 92--02-48-6933

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
middle turbinate resection
middle turbinate resection
middle turbinate resection
(Active Comparator)
middle turbinate medialization
middle turbinate medialization
middle turbinate medialization
(Active Comparator)
middle turbinate Radio Frequency (RF) turbinoplasty
middle turbinate radio frequency (rf) turbinoplasty
middle turbinate Radio Frequency (RF) turbinoplasty

Primary Outcomes

Measure
The Sino-Nasal Outcomes Test 22
time frame: three months after surgery
The Sino-Nasal Outcomes Test 22
time frame: 6 months after surgery
The Sino-Nasal Outcomes Test 22
time frame: one year after surgery

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.
Principal investigator Babak Saedi, professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.