Endoscopic Overlay Tympanoplasty for TM Perforation

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: Completed
• Conditions: Tympanic Membrane Perforation
• Intervention / Treatment: Device: Endoscopic Technique; Device: Microscopic Technique

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: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	24 hour postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audiometric parameters	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.	The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.	20th week postoperative.
Operative time	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

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Yuvatiya Plodpai, MD, Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: endoscope; microscope; transcanal
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation
• Other Study ID Numbers: REC 57-0123-13-1