Endoscopic Overlay Tympanoplasty for TM Perforation

Not Applicable

Completed

• Conditions: Tympanic Membrane Perforation
• Interventions: Device: Microscopic Technique; Device: Endoscopic Technique

• Registration Number: NCT02331797
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microscopic Technique	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.
Endoscopic Technique	Endoscopic Technique	All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.

Primary Outcome Measures

Name	Time	Method
Postoperative pain score, evaluated by Visual analogue scale.	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.

Secondary Outcome Measures

Name	Time	Method
Audiometric parameters	20th week postoperative	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.	20th week postoperative.	The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.
Operative time	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).

Trial Locations

Locations (1)

Songklanagarind Hospital; 🇹🇭 Hat Yai, Songkhla, Thailand