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

NCT06612450 | Completed DMC FDA Device

• 1 other identifier: MKSU200-289
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasal Obstruction; Turbinate Surgery

Keywords

Turbinate Hypertrophy; Coblation; Radiofrequency; Nasal obstruction

Outcome Measures

Primary Outcomes (3)

• NOSE score

  nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention

  1 year

• Pain VAS score

  patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain

  1-3 months postoperative

• Turbinate Size grading

  endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity

  1 year postoperative

Study Arms (2)

Coblation

ACTIVE COMPARATOR

patients will undergo turbinoplasty using coblation wand

Device: turbinate surgery

RaVoR

ACTIVE COMPARATOR

patients will undergo turbinate reduction using ravor radiofrequency

Device: turbinate surgery

Interventions

turbinate surgery DEVICE

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

Coblation; RaVoR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group: 18-60 years old.
• Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
• 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.
• Patients who are unfit for general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh Universitty

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 6850001, Egypt

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ibrahim Gehad

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: June 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: when results are finalized will be available for 6 months

Locations

EG (1)