Endoscopic Overlay Tympanoplasty for TM Perforation

NCT ID: NCT02331797

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-10-31

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.

Conditions

Tympanic Membrane Perforation

Keywords

endoscope; microscope; transcanal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Technique

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

Group Type: EXPERIMENTAL

Endoscopic Technique

Intervention Type: DEVICE

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)

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.

Group Type: ACTIVE_COMPARATOR

Microscopic Technique

Intervention Type: DEVICE

Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope

Interventions

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)

Intervention Type: DEVICE

Microscopic Technique

Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Yuvatiya Plodpai

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuvatiya Plodpai, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

REC 57-0123-13-1

Identifier Type: -

Identifier Source: org_study_id