Clinical trial NCT02331797: Endoscopic Overlay Tympanoplasty for TM Perforation
Official title: Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tympanic Membrane Perforation
Keywords: endoscope
microscope
transcanal
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 64
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Postoperative pain score, evaluated by Visual analogue scale.
timeFrame: 24 hour postoperative.
Secondary outcomes:
measure: Audiometric parameters
timeFrame: 20th week postoperative
measure: The intactness of graft, evaluated by endoscopic visualization, and is catergorized as perforated or healed.
timeFrame: 20th week postoperative.
measure: Operative time
timeFrame: Begining to the end of surgery
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Yuvatiya Plodpai, MD
role: PRINCIPAL_INVESTIGATOR
References: