Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-01

Brief Summary

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The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year

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Detailed Description

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Conditions

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Nasal Obstruction Turbinate Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

only one surgeon did the surgeries, other two assessors didnt know which intervention was done, the patient didn\'t know which group did they belong to

Study Groups

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Coblation

patients will undergo turbinoplasty using coblation wand

Group Type ACTIVE_COMPARATOR

turbinate surgery

Intervention Type DEVICE

Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function

RaVoR

patients will undergo turbinate reduction using ravor radiofrequency

Group Type ACTIVE_COMPARATOR

turbinate surgery

Intervention Type DEVICE

Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function

Interventions

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turbinate surgery

Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All patients with the following criteria were eligible for inclusion:

1. Age group: 18-60 years old.
2. Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
3. Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
4. Patients who are unfit for general anesthesia

Exclusion Criteria

* All Patients with:

Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No