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Completed

NCT Number: NCT02331797

Endoscopic Overlay Tympanoplasty for TM 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.

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Key information

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Technique

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

Device

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

Primary outcomes

  1. Postoperative pain score, evaluated by Visual analogue scale.

    Time frame: 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 outcomes

  1. Audiometric parameters

    Time frame: 20th week postoperative

    Evaluated by audiometry (pure tone average of air and bone conduction, air-bone gap.)

  2. The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.

    Time frame: 20th week postoperative.

    The intactness of graft is evaluated by endoscopic visualization, and is catergorized as perforated or healed.

  3. Operative time

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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