Comparison of Short and Long-term Results of Conventional Curettage Adenoidectomy Without Endoscopy Assistance Versus Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Residual adenoid tissue evaluation with Parikh grade
研究概览
简要总结
This prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.
详细描述
Residual or recurrent adenoid tissue that causes persistence or recurrence of symptoms is observed frequently after conventional cold curettage adenoidectomy. New techniques to better visualize or excise the tissue in order to prevent this situation are being developed. This study aims to compare transoral endoscopic controlled adenoidectomy with conventional blind curettage adenoidectomy in terms of recurrent adenoid hypertrophy. Although there are other studies comparing the results of the two techniques in terms of early residual adenoid tissue and bleeding, no studies comparing the long term results were found in literature. This prospective study is planned to focus on both early examination of residual tissue and long term recurrence.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients are not going to be given the detail about the days, so that they would not know which group they would be in. Care provider and investigator would not know which patient is going to be operated on which day. Outcome assessor would not know which patient received which treatment while examining for the long term results.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within 3-12 years old
- •Patients undergoing tonsillectomy and adenoidectomy for obstructive sleep disorder
- •Patients undergoing adenoidectomy and ventilation tube insertion for chronic otitis media with effusion (OME)
- •Patients undergoing adenoidectomy alone for obstructive sleep disorder
- •Patients undergoing adenoidectomy alone for chronic OME
- •Patients undergoing adenoidectomy alone for chronic sinusitis
排除标准
- •Patients not between 3-12 years old
- •Patients with craniofacial anomalies
- •Revision adenoidectomy
- •Proven significant comorbidities
- •Systemic diseases
- •Bleeding diathesis
结局指标
主要结局
Residual adenoid tissue evaluation with Parikh grade
时间窗: 1 year after surgery
Endoscopic examination of adenoid tissue postoperatively
次要结局
- Bleeding(Up to 2 weeks after surgery)
- Otitis media with effusion(Up to 1 year after surgery)
研究者
BELDAN POLAT
Associate Professor
Istanbul University