Endoscopic Overlay Tympanoplasty for TM Perforation

Prince of Songkla University

Status: Completed

Conditions: Tympanic Membrane Perforation

Treatments: Device: Endoscopic Technique; Device: Microscopic Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02331797

REC 57-0123-13-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Endoscopic Technique

Experimental group

Description:

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

Treatment:

Device: Endoscopic Technique

Microscopic Technique

Active Comparator group

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.

Treatment:

Device: Microscopic Technique