Recruitment

Recruitment Status
Unknown status

Exclusion Criterias

floppy' change of the middle turbinate in the end of surgery.
systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
any type of septoplasty indications are excluded from this study.
...
floppy' change of the middle turbinate in the end of surgery.
systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
any type of septoplasty indications are excluded from this study.
immune suppression,
revision surgery,
counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or

Summary

Conditions
  • Nasal Polyposis
  • Sinusitis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 ...

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.

Exclusion Criterias

floppy' change of the middle turbinate in the end of surgery.
systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
any type of septoplasty indications are excluded from this study.
...
floppy' change of the middle turbinate in the end of surgery.
systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
any type of septoplasty indications are excluded from this study.
immune suppression,
revision surgery,
counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or

Locations

Tehran, 94305
Tehran, 94305

Tracking Information

NCT #
NCT01906697
Collaborators
Not Provided
Investigators
  • Principal Investigator: Babak Saedi, professor Tehran University of Medical Sciences
  • Babak Saedi, professor Tehran University of Medical Sciences