Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prince of Songkla University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Postoperative pain score, evaluated by Visual analogue scale.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Endoscopic Technique
All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.
Intervention: Endoscopic Technique (Device)
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.
Intervention: Microscopic Technique (Device)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Yuvatiya Plodpai
Doctor
Prince of Songkla University