Endoscopic Overlay Tympanoplasty for TM Perforation

Tympanic Membrane Perforation Clinical Trial

Official title:

Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331797
• Other study ID #: REC 57-0123-13-1
• Status: Completed
• Phase: N/A
• First received: December 26, 2014
• Last updated: December 18, 2017
• Start date: December 2014
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

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

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Audiometric parameters	Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)	20th week postoperative
Secondary	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.
Secondary	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