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Endoscopic Overlay Tympanoplasty for TM Perforation

Primary Purpose

Tympanic Membrane Perforation

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Endoscopic Technique
Microscopic Technique
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation focused on measuring endoscope, microscope, transcanal

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Songklanagarind Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic Technique

Microscopic Technique

Arm Description

All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.

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.

Outcomes

Primary Outcome Measures

Postoperative pain score, evaluated by Visual analogue scale.
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.

Secondary Outcome Measures

Audiometric parameters
Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)
The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Operative time
The actual operating time is recorded from beginning of local anesthetic injection to the end of the surgery (complete skin suturing).

Full Information

First Posted
December 26, 2014
Last Updated
December 18, 2017
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT02331797
Brief Title
Endoscopic Overlay Tympanoplasty for TM Perforation
Official Title
Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanic Membrane Perforation
Keywords
endoscope, microscope, transcanal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Technique
Arm Type
Experimental
Arm Description
All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.
Arm Title
Microscopic Technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endoscopic Technique
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Microscopic Technique
Intervention Description
Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope
Primary Outcome Measure Information:
Title
Postoperative pain score, evaluated by Visual analogue scale.
Description
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.
Time Frame
24 hour postoperative.
Secondary Outcome Measure Information:
Title
Audiometric parameters
Description
Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)
Time Frame
20th week postoperative
Title
The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Description
The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Time Frame
20th week postoperative.
Title
Operative time
Description
The actual operating time is recorded from beginning of local anesthetic injection to the end of the surgery (complete skin suturing).
Time Frame
Begining to the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuvatiya Plodpai, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songklanagarind Hospital
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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Endoscopic Overlay Tympanoplasty for TM Perforation

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