跳至主要内容
临床试验/NCT04572503
NCT04572503招募中不适用

Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndrome

Benha University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Apnea Hypopnea index

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (OSAS).

详细描述

A prospective analytic study will be conducted on a total number of 20 patients presented with mild to moderate obstructive sleep apnea for whom Barbed suture modified anterior palatoplasty will be performed.

Surgical Steps

  • Procedure will be performed under general anesthesia
  • Bilateral tonsillectomy will be performed.
  • Then, the inferior portion between upper 2/3 and inferior 1/3 of palatopharyngeus muscle will be partially released
  • Then, a rectangular shaped strip of mucosa and the underlying submucosa will be removed at the center of the soft palate consisting of 0.5-0.7 mm in length and with width corresponding to the tonsillar fossae distance.
  • Then,the stripped area will be sutured by single resorbable polydioxanone barbed bidirectional size 0 monofilament suture by introducing one needle at the center point of the wound then will be passed laterally within the palate, turning around pterygomandibular raphe till it comes out at the most superior part of the raphe at one side the thread will be pulled until it hangs at the central transition zone which is a free zone present between the two directions of the thread.
  • Then, again the needle will be passed back through the tonsillectomy bed and then this suture will be suspended around the raphe again; a gentle traction is then applied on the thread only and no knots are taken.T
  • The opposite side will be done by the same way.
  • Finally, each thread will be come out at the raphe of the same side, for locking of the stitches and looseness prevention; a superficial stitch in the opposite direction is taken, and then the thread is cut while bushing the tissue downward for more traction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild to moderate obstructive sleep apnea syndrome.
  • Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses
  • Patients who are noncompliant with Continuous positive airway pressure (CPAP).

排除标准

  • Patients diagnosed with sever OSAS (AHI more than 30)
  • The main site of obstruction at retrolingual level or multilevel obstruction.
  • Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency).
  • Patients with significant craniofacial anomalies affecting airway.
  • Patients with BMI>40 kg/m
  • Patients unfit for general anesthesia.
  • History of previous velopharyngeal or lingual surgeries.

结局指标

主要结局

Apnea Hypopnea index

时间窗: 6 months

one-night polysomnographic study at sleep lab. The apnea-hypopnea index denotes the total numbers of apnea plus hypopnea events divided by total sleep time in hours (0-5/ hr sleep = mild, 6-15/hr sleep = moderate, more than 15/hr sleep = severe)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrahman Ahmed Abdelalim

MD Lecturer

Benha University

研究点 (2)

Loading locations...

相似试验