Endoscopic Overlay Tympanoplasty for TM Perforation

NCT02331797 | Completed DMC

• 1 other identifier: REC 57-0123-13-1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Tympanic Membrane Perforation

Keywords

endoscope; microscope; transcanal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Audiometric parameters

  20th week postoperative

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

  20th week postoperative.

• Operative time

  Begining to the end of surgery

Study Arms (2)

Endoscopic Technique

EXPERIMENTAL

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

Device: Endoscopic Technique

Microscopic Technique

ACTIVE COMPARATOR

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.

Device: Microscopic Technique

Interventions

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)

Endoscopic Technique

Microscopic Technique DEVICE

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

Microscopic Technique

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Yuvatiya Plodpai, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

TH (1)