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The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Babak Saedi, Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906697
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
  Purpose
The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization

Condition Intervention Phase
Nasal Polyposis Sinusitis Procedure: middle turbinate Radio Frequency (RF) turbinoplasty Procedure: middle turbinate resection Procedure: middle turbinate medialization Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.

Further study details as provided by Babak Saedi, Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 90
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906697


Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 94305
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Babak Saedi, professor Tehran University of Medical Sciences
  More Information

Responsible Party: Babak Saedi, Associate professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01906697     History of Changes
Other Study ID Numbers: 92--02-48-6933
First Submitted: July 19, 2013
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical