The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

NCT ID: NCT01906697

Last Updated: 2013-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Nasal Polyposis Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group B

middle turbinate resection

Group Type ACTIVE_COMPARATOR

middle turbinate resection

Intervention Type PROCEDURE

middle turbinate resection

group C

middle turbinate medialization

Group Type ACTIVE_COMPARATOR

middle turbinate medialization

Intervention Type PROCEDURE

middle turbinate medialization

group A

middle turbinate Radio Frequency (RF) turbinoplasty

Group Type ACTIVE_COMPARATOR

middle turbinate Radio Frequency (RF) turbinoplasty

Intervention Type PROCEDURE

middle turbinate Radio Frequency (RF) turbinoplasty

Interventions

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middle turbinate Radio Frequency (RF) turbinoplasty

middle turbinate Radio Frequency (RF) turbinoplasty

Intervention Type PROCEDURE

middle turbinate resection

middle turbinate resection

Intervention Type PROCEDURE

middle turbinate medialization

middle turbinate medialization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Babak Saedi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Babak Saedi, professor

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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92--02-48-6933

Identifier Type: -

Identifier Source: org_study_id

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