The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates
Primary Purpose
Nasal Polyposis, Sinusitis
Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
middle turbinate Radio Frequency (RF) turbinoplasty
middle turbinate resection
middle turbinate medialization
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Polyposis
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.
Sites / Locations
- Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
group B
group C
group A
Arm Description
middle turbinate resection
middle turbinate medialization
middle turbinate Radio Frequency (RF) turbinoplasty
Outcomes
Primary Outcome Measures
The Sino-Nasal Outcomes Test 22
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
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
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Secondary Outcome Measures
Full Information
NCT ID
NCT01906697
First Posted
July 19, 2013
Last Updated
July 23, 2013
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01906697
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyposis, Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group B
Arm Type
Active Comparator
Arm Description
middle turbinate resection
Arm Title
group C
Arm Type
Active Comparator
Arm Description
middle turbinate medialization
Arm Title
group A
Arm Type
Active Comparator
Arm Description
middle turbinate Radio Frequency (RF) turbinoplasty
Intervention Type
Procedure
Intervention Name(s)
middle turbinate Radio Frequency (RF) turbinoplasty
Intervention Description
middle turbinate Radio Frequency (RF) turbinoplasty
Intervention Type
Procedure
Intervention Name(s)
middle turbinate resection
Intervention Description
middle turbinate resection
Intervention Type
Procedure
Intervention Name(s)
middle turbinate medialization
Intervention Description
middle turbinate medialization
Primary Outcome Measure Information:
Title
The Sino-Nasal Outcomes Test 22
Description
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Time Frame
three months after surgery
Title
The Sino-Nasal Outcomes Test 22
Description
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Time Frame
6 months after surgery
Title
The Sino-Nasal Outcomes Test 22
Description
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Time Frame
one year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Saedi, professor
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
94305
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates
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