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临床试验/NCT07417007
NCT07417007已完成不适用

COMPARATIVE ANALYSIS OF COLD CURETTAGE AND COBLATION ADENOIDECTOMY: SURGICAL AND POSTOPERATIVE OUTCOMES WITH 0° AND 70° ENDOSCOPIC TECHNIQUES

Medipol University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Residual Adenoid Tissue Rate

研究概览

简要总结

Adenoidectomy is a common pediatric otolaryngologic procedure. While cold curettage remains widely practiced, endoscopic coblation has been developed to enhance precision, minimize intraoperative complications, and reduce residual tissue. This study compared outcomes of conventional cold curettage adenoidectomy and coblation-assisted adenoidectomy in pediatric patients.

详细描述

A total of 128 pediatric patients aged 3-11 years who underwent adenoidectomy between August 2024 and August 2025 was prospectively evaluated with a follow-up duration of 6-12 months. (Table 1) Of these, 64 underwent adenoidectomy and/or myringotomy with ventilation tube insertion using the conventional cold curettage method, while the remaining 64 underwent the same procedures using the endoscopic coblation technique with 0° or 70° endoscopes. All patients had been diagnosed with adenoid hypertrophy and were unresponsive to medical treatment. Indications for surgery included nasal obstruction and associated symptoms such as snoring, apnea, mouth breathing during sleep, recurrent otitis media, and hearing loss due to serous otitis media.

Exclusion criteria included patients who underwent concurrent tonsillectomy, dental procedures, or nasal surgeries such as septoplasty and/or turbinate reduction. Patients with chronic neurological disorders or cleft palate were also excluded. Informed consent was obtained from all participants prior to inclusion in the study.

All patients underwent a detailed anamnesis and clinical examination. Following the application of a nasal decongestant spray, nasal endoscopy was performed, and the size and position of the adenoid tissue were scored from 1 to 4 using the McMurray and Clemens scoring system.4 In patients who were uncooperative or for whom endoscopic examination could not be performed, lateral nasopharyngeal radiographs were taken to allow for grading. During the operation, the size and extent of the adenoid tissue were confirmed transnasally or transorally using 0° or 70° rigid endoscopes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adenoid hypertrophy and were unresponsive to medical treatment. Indications for surgery included nasal obstruction and associated symptoms such as snoring, apnea, mouth breathing during sleep, recurrent otitis media, and hearing loss due to serous otitis media.

排除标准

  • Exclusion criteria included patients who underwent concurrent tonsillectomy, dental procedures, or nasal surgeries such as septoplasty and/or turbinate reduction. Patients with chronic neurological disorders or cleft palate were also excluded

研究组 & 干预措施

Cold Curettage Adenoidectomy

Experimental

Conventional adenoidectomy performed using cold curettage technique.

干预措施: Cold Curettage Adenoidectomy (Procedure)

Coblation-Assisted Adenoidectomy

Experimental

Endoscopic adenoidectomy performed using coblation technology.

干预措施: Coblation-Assisted Adenoidectomy (Procedure)

结局指标

主要结局

Residual Adenoid Tissue Rate

时间窗: During the follow-up assessments at 1, 6, and 12 months postoperatively

Presence of residual adenoid tissue evaluated postoperatively.

次要结局

  • Operative Time(During surgery)
  • Intraoperative Complications(During Surgery)
  • Intraoperative Blood Loss(During Surgery)
  • Postoperative Pain(Post operative 24 hours and at the 72nd hour)
  • Halitosis(Postoperative two weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lütfü Şeneldir

MedipolU

Medipol University

研究点 (1)

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