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临床试验/NCT06983860
NCT06983860尚未招募不适用

Application and Demonstration of Endoscope-assisted Low-temperature Plasma Radiofrequency Ablation Resection of Tonsils

People's Hospital of Anshun City of Guizhou Province0 个研究点目标入组 100 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Perioperative indexes

研究概览

简要总结

Low temperature plasma radiofofency ablation of tonsil under 70° nasal endoscope can directly view the lesion area on the monitor, clearly enlarge the operating field, and has the advantages of small surgical trauma, good hemostatic effect, light postoperative pain, low probability of postoperative bleeding and quick postoperative recovery of patients, etc. It is a good surgical mode integrating surgery and teaching, and has brought great benefits to patients, and is worth promoting and applying.

详细描述

  1. Basis for Project Initiation 1.1 Chronic tonsillitis is a common health issue that can significantly impact the patient's quality of life.

Chronic tonsillitis is a common condition in the field of otolaryngology, primarily caused by recurrent episodes of acute tonsillitis that persist and fail to heal, leading to degeneration and necrosis of epithelial cells within the gland. This results in the retention of pathogenic microorganisms and inflammatory exudates, causing blockage of the crypt drainage, which then leads to secondary infections and eventually evolves into chronic inflammation[1]. Clinically, it manifests mainly with symptoms such as frequent colds, discomfort during swallowing, a sensation of something foreign in the throat, dryness in the throat, bad breath, paroxysmal coughing, headaches, and more. In severe cases, it can cause difficulty in breathing, sleep apnea, and even lead to complications like acute nephritis, rheumatic arthritis, heart disease, and scarlet fever, significantly impacting both the physical and mental health of patients, severely affecting their quality of daily life.

1.2 Traditional tonsillectomy is associated with significant trauma and numerous complications, whereas the low-temperature plasma knife causes minimal trauma and offers excellent hemostatic effects.

For chronic tonsillitis patients with recurrent acute tonsillitis, peritonsillar abscess, excessive hypertrophy of tonsils, repeated acute attacks, sleep apnea and neighboring organs involved, surgical treatment is often used in clinic. The surgical methods of tonsillectomy mainly include two categories: one is cold instrument surgery, including traditional tonsillectomy and extrusion; The second is hot instrument surgery, including the application of laser, high-frequency electrotome, low temperature plasma radio frequency surgery. Due to the abundant blood supply of the tonsil, traditional surgery is prone to cause damage and bleeding of arteries and accompanying veins and venous plexus, which affects the surgical field of view and leads to poor hemostatic effect of the wound during the operation, thus prolonging the operation time and affecting the prognosis. Studies have shown that in the process of traditional tonsillectomy, tissues around the knife edge need to be drawn into the sheath, which excessively stretches the tonsils, causing damage to some normal tissues and increasing postoperative pain. In addition, due to insufficient visual field, over-deep resection is likely to result in incomplete intraoperative hemostasis and residual, which is likely to lead to primary postoperative hemorrhage and excessive postoperative pharyngeal activity. It will promote postoperative complications, which is not conducive to postoperative recovery .

With the development of minimally invasive technology, low-temperature plasma radiofrequency ablation has been widely used in various soft tissue surgeries in otorhinolaryngology in recent years, showing advantages such as less trauma, quick postoperative recovery and good prognosis . The application of low-temperature plasma knife in tonsillectomy integrates the functions of surgical cutting, hemostasis and suction, which can clearly separate the tonsil envelope and surrounding tissues, and at the same time draw out blood to clean the wound, thus shortening the operation time and reducing the amount of intraoperative blood loss [15]. The surgical field of view is clear, the damage to the surrounding large blood vessels and muscle tissue is small, and the mechanical damage caused by traditional dissection can be avoided. At the same time, the mucosal tissue of the pharyngeal cavity can be preserved to the maximum extent, which has little impact on the function of the pharyngeal cavity and is conducive to the guarantee of treatment safety. In addition, low-temperature incision wound is more orderly, and can immediately form a protein false film to cover the wound, reduce the stimulation of nerve endings, and help reduce the degree of postoperative pain, so as to promote the early recovery of patients, comprehensively improve the prognosis and improve the quality of life of patients .

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
3 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •History of recurrent acute attacks of chronic tonsillitis, with the number of attacks >3 times per year for more than 2 years;
  • •accompanied by snoring, choking and apnea during night sleep;
  • •Age 3-65 years old, gender is not limited;
  • •No major systemic diseases, such as cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, hematopoietic system diseases;
  • •Subjects who can understand and abide by the research procedures and voluntarily participate in the experiment by signing the informed consent form (the informed consent is signed by themselves or their legal representatives).

排除标准

  • •cardiopulmonary insufficiency;
  • •Patients with systemic blood diseases;
  • •Patients with acute and chronic bronchial or lung infections;
  • •Complicated with severe cardiovascular system disease or hepatic and renal insufficiency;
  • •Patients with mental abnormalities or who do not cooperate with treatment 7) Researchers who are participating in other trials.

研究组 & 干预措施

endoscope-assisted low-temperature plasma radiofrequency ablation resection of tonsils

Experimental

In this prospective study, 100 patients admitted to our hospital for tonsillectomy from January 2025 to December 2025 will be recruited as experimental subjects. Perioperative indexes (operation time, intraoperative blood loss, length of hospital stay) were recorded. Visual Analogue Scale (VAS) was used: VAS scores were performed at 6h, 12h, 24h and 72h after surgery. Endoscopic examination: On the 2nd, 4th, 2nd and 4th postoperative days, the formation and shedding of tonsillar fossa were observed through the mouth under a 70-degree nasal endoscope. Whether there is bleeding or bleeding in the operative area; The recovery of the operative area and the presence or absence of granulation tissue hyperplasia. Postoperative bleeding and complications were recorded.

干预措施: Application and demonstration of endoscope-assisted low-temperature plasma radiofrequency ablation resection of tonsils (Procedure)

结局指标

主要结局

Perioperative indexes

时间窗: intraoperative

operation time, intraoperative blood loss, length of hospital stay

Visual Analogue Scale (VAS)

时间窗: VAS score was performed at 6h, 12h, 24h and 72h after surgery

VAS score is a widely used subjective assessment method for pain assessment. Using a walking scale about 10cm long, one side is marked with 10 scales, and the two ends are respectively "0" and "10". 0 indicates no pain, and 10 indicates unbearable pain. The patient is asked to mark the pain value and record it.

Endoscopic examination

时间窗: On the 2nd, 4th, 2nd and 4th postoperative days

the formation and shedding of tonsillar fossa in the operative area were observed through the mouth under a 70-degree nasal endoscope; Whether there is bleeding or bleeding in the operative area; The recovery of the operative area and the presence or absence of granulation tissue hyperplasia

次要结局

  • Postoperative bleeding(Within 1 month after surgery)
  • The occurrence of complications was recorded.(Within 1 month after surgery)

研究者

发起方
People's Hospital of Anshun City of Guizhou Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangjun Tang

Doctor

People's Hospital of Anshun City of Guizhou Province

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