Radiofrequency Ablation Versus Lateralization as Office-Based Procedures for Bilateral Inferior Turbinate Hypertrophy

Summary

: Patient Information Sheet and Informed Consent Form PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM (for adult subjects and interventional studies)

1. Title of study:

A Prospective, Randomized, Comparative Study between Lateralization Vs Radiofrequency Ablation for Patients with Bilateral Inferior Turbinates Hypertrophy
2. Name of investigator and institution:

Dr Ong Hui Yan (Principal Investigator), Jabatan Otorhinolaryngology, Pusat Purubatan Universiti Malaya/ Hospital Tengku Ampuan Rahimah Klang Dr Ng Jia Ji (Co-investigator), Jabatan Otorhinolaryngology, Hospital Tengku Ampuan Rahimah Dr Shashi Gopalan (Supervisor), Jabatan Otorhinolaryngology, Hospital Tengku Ampuan Rahimah
3. Name of sponsor:

This is a self-sponsored study
4. Introduction:

You are invited to participate in a research study because you have nose blockage which are not responding to medical treatment and may require surgical intervention. If you are not keen for operation in the operating theatre, we may offer procedures which can be done in clinic setting.

It is important that you understand why the research is being done and what it will involve. Please take your time to read through and consider this information carefully before you decide if you are willing to participate. Ask the study staff if anything is unclear or if you like more information. After you are properly satisfied that you understand this study, and that you wish to participate, you must sign this informed consent form. To participate in this study, you may be required to provide you doctor with information on your health history; you may harm yourself if you are not truthful with the information provided.

Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You may also refuse to answer any questions you do not want to answer. If you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal will still be used for the study. Your refusal to participate or withdrawal will not affect any medical or health benefits to which you are otherwise entitled.

This study has been approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia.
5. What is the purpose of the study?

The purpose of this study is to compare between 2 clinic procedures which we perform under clinic setting for patients with nose obstruction due to enlarged turbinates. We are comparing the outcomes between these 2 procedures. This research can help us to decide on the most effective and safe procedure for patients with similar problem.

There are surgical interventions which are more effective from literature and we are performing them in the operating theatre, and requires full body anesthesia. If you are not keen for that, the 2 clinical procedures listed in this study will be an alternative. If you are agreeable for the study, you will only be subjected to only 1 of the procedures. The current procedure that we are rountinely doing now in our clinic is to shrink the turbinates by using a machine. Another procedure that we are comparing with is faster and requires only simple instrument.

Both of the procedures carry similar risks, such as pain, bleeding and crusting and recurrences. Both the procedures involved are performed in clinic and do not require admission.

180 participants will be included in this study.

The whole study will last about 3 months and your participation will be about 3 months.

6\. What kind of study procedures will I receive?

If you agree to participate in the study, you will be randomly assigned to one of the treatment groups below. You have equal chance of being assigned to each of the group.

Group 1: Radiofrequency ablation of the inferior turbinates (using machine to burn and shrink the enlarged turbinates in your nose)

Group 2: Lateralization of the inferior turbinates (using an instrument to manipulate and push aside the turbinates)

Both of the procedures aim to reduce the size of the enlarged turbinates and to improve your nose blockage.

Both of the procedures carry similar risk and side-effects, such as pain, bleeding, crusting and recurrence of symptoms.

Only the principal investigator and the co-investigator will perform the procedure for you, and it will be supervised by the study supervisor.

7\. What will happen if I decide to take part?

* You will first be examined on your nose condition by using a scope.
* The size of your turbinates will be documented.
* You will be given a set of questionnaire regarding your nose condition to fill up
* Your nose will be sprayed on either side, 2 puffs each of the decongestant spray.
* You will be given painkiller via injections over the inner side of your nose
* Cotton with medication will be inserted into your nose for 5 minutes
* Either 1 of the procedures will b performed
* After the procedure, you will be monitored for 15 minutes

Conditions

• Inferior Turbinates Hypertrophy
• Nasal Obstruction

Interventions

DEVICE

Radiofrequency ablation of inferior turbinates

Both are office procedures that can be done in clinic and we would like to determine the effectiveness of both.

DEVICE

Lateralization of inferior turbinates

Lateralization of inferior turbinates with freer elevator

Sponsors & Collaborators

• Goh Liang Chye

  lead OTHER

Principal Investigators

• Liang Chye Goh, MBBS, MS ORL HNS · University of Malaya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-17

Primary Completion

2022-01-17

Completion

2022-06-17

FDA Device

Yes

Countries

• Malaysia

Study Locations