Endoscopic Overlay Tympanoplasty for TM Perforation

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02331797
• Date of registration: 26/12/2014
• Prospective Registration: No
• Primary sponsor: Prince of Songkla University
• Public title: Endoscopic Overlay Tympanoplasty for TM Perforation
• Scientific title: Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
• Date of first enrolment: December 2014
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02331797
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Yuvatiya Plodpai, MD
• Affiliation: Prince of Songkla University

Key inclusion & exclusion criteria

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



Age minimum: 15 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tympanic Membrane Perforation

Intervention(s)

Device: Microscopic Technique

Device: Endoscopic Technique

Primary Outcome(s)

Postoperative pain score, evaluated by Visual analogue scale. [Time Frame: 24 hour postoperative.]

Secondary Outcome(s)

Operative time [Time Frame: Begining to the end of surgery]

The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed. [Time Frame: 20th week postoperative.]

Audiometric parameters [Time Frame: 20th week postoperative]

Secondary ID(s)

REC 57-0123-13-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors