Endoscopic Overlay Tympanoplasty for TM Perforation

December 18, 2017 updated by: Yuvatiya Plodpai, Prince of Songkla University

Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation

Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. The investigators conduct this study to compared post operative pain score (by Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A main part of tympanoplasty is repair of perforated tympanic membrane. There are two popular way to approach tympanic membrane, transcanal or postauricular approach. There are two grafting techniques are applied in tympanoplasty which includes the lateral technique (overlay) and medial technique (underlay).

The lateral technique is widely used in our institute which involves placement of a graft lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. The most our preferred approach in previous experience is the postauricular approach for tympanoplasty because the transcanal approach is not enough for adequate exposure. Moreover, the visualization straight through transcanal provide by the microscope is difficult by a limited view of the perforation edge due to narrowing and curved external ear canal. Postauricular approach cause many layers of tissue are violated along with a significant postoperative pain.

The author proposed this study with the aim of determining the alleviation of postoperative pain by new technique and the efficacy of endoscope for tympanoplasty.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Songklanagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 15-70 years
  • The patients who had perforation of tympanic membrane
  • The perforations are all dry at the time of surgery and have been dry for at least 3 months.
  • No contraindication for local or general anesthesia.
  • No recent upper respiratory tract infection at least 2 weeks before surgery.
  • No unstable underlying condition.
  • Have at least 2 months of follow up.
  • Agree to participate in the study
  • Aaccept to be randomized to receive treatment
  • Willing to sign an informed consent

Exclusion Criteria:

  • Medial placing or inlay surgical technique
  • Chronic otitis media
  • Contraindication of vasoconstriction agent (adrenaline)
  • Allergy to analgesic agent (Xylocaine or Lidocaine)
  • Concomitant with mastoiditis.
  • Previous intracranial or extra-cranial complication of chronic otitis media.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endoscopic Technique
All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.
Device: Endoscopic Technique
Endoscopic Technique; endoscopic transcanal lateral graft tympanoplasty using An endoscope (Karl Storz, Tuttlingen, Germany) and A microdrill (Skeeter Otologic Drill System; Medtronic Xom ed Surgical Products, Inc., Jacksonville, FL, USA)
Active Comparator: Microscopic Technique
All patients are operated under the microscope.A postauricular or transcanal approach is chose depend on ear canal size and size of perforation. When the ear canal is too small, the postauricular is used.
Device: Microscopic Technique
Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative pain score, evaluated by Visual analogue scale.
Time Frame: 24 hour postoperative.
Evaluate pain score by Visual analogue scale. Patients are asked to score their pain on visual analogue scale at 4 hour, 24 hour and 48 hour postoperative.
24 hour postoperative.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Audiometric parameters
Time Frame: 20th week postoperative
Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)
20th week postoperative
The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Time Frame: 20th week postoperative.
The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.
20th week postoperative.
Operative time
Time Frame: Begining to the end of surgery
The actual operating time is recorded from beginning of local anesthetic injection to the end of the surgery (complete skin suturing).
Begining to the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prince of Songkla University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuvatiya Plodpai, MD, Prince of Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC 57-0123-13-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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