Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,250
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Tonsillectomy, with or without adenoidectomy, in both children and adults is worldwide one of the most commonly performed surgical procedures in otorhinolaryngology, and the number is increasing. Alone in Denmark, approximately 8.000 tonsillectomies are performed annually. Although, tonsillectomy on benign indication is considered to be a minor and frequently performed surgical procedure, the operation is associated with significant morbidity. Postoperative pain and post tonsillectomy haemorrhage (PTH) are the most frequent, and PTH is potentially life threatening. In cold steel tonsillectomy, the peritonsillar space is dissected with metal instruments, and bleeding is typically controlled by ligation or electrocautery. This method has been used for the past 50 years, and is considered the "Gold Standard". However, new so-called "hot techniques have been developed. One of these is an impedance-dependent tissue sealer device (BiZactTM). The equipment used for BiZactTM tonsillectomy is EC certificated (CE nr. 00500). The equipment is commonly used for tonsillectomy both internationally and in Denmark, and preliminary results in both adults and children are promising. However, when a gold standard technique is replaced by a new technique, it is recommended that the decision is based on evidence obtained in randomized controlled designs, and preferably as a multicenter study.
Within the scope of the CE marking of the equipment, the purpose of the present study is to conduct a randomized controlled trial (RCT) in order to investigate whether tonsillectomy performed with BiZactTM "hot" technique is beneficial or at least non-inferior compared to the gold standard cold steel technique in terms of affecting the incidence of post-tonsillectomy morbidity, interoperative factors, patient satisfaction, and health related quality of life.
详细描述
Tonsillectomy, with or without adenoidectomy, conducted in both children and adults is worldwide one of the most commonly performed surgical procedures in otorhinolaryngology, and the number of tonsillectomies has increased over the recent decades. In Denmark, approximately 8.000 tonsillectomies are performed annually. The main indications for surgery are recurrent episodes of acute tonsillitis or upper airway obstruction due to adenotonsillar hypertrophy.
Although commonly performed, tonsillectomy is associated with significant morbidity of which postoperative pain and post tonsillectomy haemorrhage (PTH) are the most frequent. PTH is a major and potentially life-threatening complication of tonsil surgery. Postoperative pain lasts for approximately two weeks, and may in severe cases result in delayed discharge, a visit at the emergency department or readmission for pain control, re-hydration, and treatment of possible underlaying infection. The incidences of PTH vary between 0.3 and more than 10%. This variation may be caused by different definitions of PTH, but also differences in populations and indications. Cold steel tonsillectomy is considered to be the gold standard surgical technique, but several hot techniques including bipolar techniques, diathermy, and coblation have been developed and used for tonsillectomy. Until now these hot instruments have not proven better than the gold standard technique in reducing PTH, and it is recommended, that these hot techniques should be used with caution. Recently, a new Impedance-dependent tissue sealer device (BiZactTM) has been manufactured and approved for tonsil operations (19). Preliminary results are promising in terms of a PTH rate of 4.5%, a shortened operative time in the hands of both experienced and training surgeons with a median time of 5.1 minutes (range 1.5-26.5 minutes), and a reduced intraoperative blood loss between 1-10 milliliters.
Ideally, when a gold standard technique is replaced by a new technique, it is recommended that the decision should be based on evidence provided by RCTs involving several centers.
The aim of the present is to conduct a RCT to investigate whether tonsillectomy performed with a new hot technique (BiZactTM) is beneficial or at least non-inferior to the gold standard cold steel technique in terms of incidence of post-tonsillectomy morbidity, interoperative factors, patient satisfaction, and health related quality of life.
The study design is a double blind, multi-centre randomised controlled trial (RCT).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstruction/ tonsillar hypertrophy.
- •Recurrent tonsillitis, including previous peritonsillar abscess
- •Chronic tonsillitis
- •Systemic complications to tonsillitis (glomerulonephritis)
- •Other (Mononucleosis), PFAPA (Periodic Fever, Aphtous stomatitis, pharyngitis, cervical adenitis)
- •Foetor ex ore (tonsillar plugs)
- •Peritonsillar abscess (Tonsillectomy a chaud)
- •Ability to understand the written patient information and to give informed consent
排除标准
- •Diseases in the hematopoietic system
- •Antithrombotic or anticoagulant drugs in the recovery period
- •Suspicion of/known tonsillar malignancies or other malignancy
- •Patients or caregivers unable to read or speak Danish
- •Patients or caregivers unable to use online application for self-evaluation
结局指标
主要结局
Postoperative pain
时间窗: From the day of surgery until 14 days after the surgery
• Postoperative pain assessed on a 11point numeric rating scale ranging from 0 "no pain" to 10 "worst possible pain". The Wong-Baker Faces rating scale is used for children.
Incidence of PTH
时间窗: 24 hours until 30 days after surgery
• Incidence of PTH defined as haemorrhage requiring haemostasis with; bipolar electric coagulation, ligature, compression and/or medical treatment with antifibrinolyticum within the first 24 hours after surgery until 30 days after surgery.
次要结局
- Knife time(First day of surgery)
- Smell and taste(From the day of the surgery until 6 months after the surgery)
- PROM(From the day of the surgery until 6 months after the surgery)
- Blood loss(Intraoperative)
- Health related quality of life(From the day of the surgery until 6 months after the surgery)
- Unscheduled contacts to the health care system(From the day of the surgery until 14 days after)
研究者
Line Schiøtt Nissen
MD
Regional Hospital West Jutland