Endoscopic Overlay Tympanoplasty in Correcting Large Tympanic Membrane Perforation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Postoperative pain score, evaluated by Visual analogue scale.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endoscopic Technique
All patients are operated under the endoscope. The endoscope passed through external auditory canal (transcanal approach) to visualize tympanic remnant.
干预措施: 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.
干预措施: Microscopic Technique (Device)
结局指标
主要结局
Postoperative pain score, evaluated by Visual analogue scale.
时间窗: 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.
次要结局
- 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)
研究者
Yuvatiya Plodpai
Doctor
Prince of Songkla University