跳至主要内容
临床试验/CTRI/2024/12/078276
CTRI/2024/12/078276招募中不适用

Study evaluating the effectiveness of composite cartilage grafts vs temporalis fascia graft in tympanoplasty - Randomised controlled trial

Arupadai Veedu Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Tympanic membrane closure success rate assessed by otoscopy and audiometry at specified follow-up intervals

研究概览

简要总结

Tympanoplasty, a surgical procedure aimed at repairing the tympanic membrane (eardrum), has been a cornerstone in the management of various middle ear pathologies, including chronic otitis media and tympanic membrane perforations. The success of tympanoplasty largely depends on the choice of graft material utilized for the reconstruction of the tympanic membrane. Among the commonly employed graft materials, temporalis fascia and composite cartilage-perichondrium grafts have gained significant attention due to their unique properties and favourable outcomes reported in clinical practice.

Temporalis fascia, harvested from the temporalis muscle, has been widely utilised in tympanoplasty for decades. Its pliability, availability, and low immunogenicity make it a popular choice among otologic surgeons. However, concerns regarding its long-term durability and propensity for retraction have led to the exploration of alternative graft materials.

In recent years, one-piece composite cartilage-perichondrium grafts have emerged as a promising alternative to temporalis fascia. Comprising both cartilage and perichondrium layers harvested from the tragus or conchal bowl, these grafts offer structural support, stability, and reduced risk of retraction. Moreover, they possess inherent vascularization, potentially promoting better graft incorporation and long-term outcomes.

Despite the growing body of literature comparing these graft materials, there remains a lack of consensus regarding the optimal choice for tympanoplasty. While some studies have demonstrated superior outcomes with composite cartilage-perichondrium grafts, others have reported comparable success rates between the two materials. Therefore, a comprehensive comparative analysis is warranted to elucidate the advantages and limitations of temporalis fascia and composite cartilage-perichondrium grafts in tympanoplasty.

This study is a comparative analysis of types of grafts used in comparison with the tympanic membrane perforation and post operative assessment with audiology and otoendoscopic findings and hence conclude on graft of choice for tympanoplasty in a coastal region.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All cases of Tubotympanic type of CSOM with perforation of the tympanic membrane with dry ear Includes patient in the age group of 18–60 years.

排除标准

  • All cases of Attico antral type of CSOM.
  • Patients with craniofacial abnormalities (cleft palate).
  • Otogenic intra cranial complications in the past.
  • External ear infective conditions.
  • Pre operative ossicular discontinuity, fixed foot plate.
  • Patients with evidence of focal sepsis.

结局指标

主要结局

Tympanic membrane closure success rate assessed by otoscopy and audiometry at specified follow-up intervals

时间窗: 3weeks, 6 weeks & 12 weeks

次要结局

  • Improvement in pure tone audiometry (PTA) thresholds, postoperative complications (e.g., graft displacement, infection), and patient-reported outcomes (e.g., subjective hearing improvement, satisfaction with surgery).(3weeks, 6 weeks & 12 weeks)

研究者

发起方
Arupadai Veedu Medical College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anirudh Gaekwad

AARUPADAI VEEDU MEDICAL COLLEGE

研究点 (1)

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