The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

July 23, 2013 updated by: Babak Saedi, Tehran University of Medical Sciences

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: group B
middle turbinate resection
Procedure: middle turbinate resection
middle turbinate resection
Active Comparator: group C
middle turbinate medialization
Procedure: middle turbinate medialization
middle turbinate medialization
Active Comparator: group A
middle turbinate Radio Frequency (RF) turbinoplasty
Procedure: middle turbinate Radio Frequency (RF) turbinoplasty
middle turbinate Radio Frequency (RF) turbinoplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Sino-Nasal Outcomes Test 22
Time Frame: 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.
three months after surgery
The Sino-Nasal Outcomes Test 22
Time Frame: 6 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.
6 months after surgery
The Sino-Nasal Outcomes Test 22
Time Frame: 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.
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tehran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Babak Saedi, professor, Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 92--02-48-6933

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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