Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- surgical time
研究概览
简要总结
Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous. Constant evaluation of surgical techniques is paramount to improve safety and cost-effectiveness. Frequently tonsillectomies are performed in cold steel technique. Aim of this study will be the evaluation of handling, surgical time, postoperative pain and postoperative hemorrhage rates using the BiZactTM-Device in comparison to traditional techniques on the contralateral side. In one patient, two different techniques will be used.
The primary objective will be the surgical time. Regardless of surgeon handedness, surgeons will randomly be assigned to either start with the left or right tonsil, and randomly either to start with the BiZact™ Device or with "cold steel" methods.
Additionally, time to stop bleeding, intraoperative blood loss, tonsil mobility, device handling, as well as wound healing will be assessed.
详细描述
Although stricter indication criteria have been implanted (especially in Austria since 2008), tonsillectomies are still performed very frequently. Post-surgical bleeding can potentially be life-threatening, and occur within 3 weeks after tonsillectomy. A broad survey in Great Britain revealed a postoperative hemorrhage rate in 33.921 patients between 1.5 and 5.4 %, varying on hospital size. Small collectives also showed rates up to 21.7%.
Worldwide, different techniques are used. Generally, "cold" steel and "hot" techniques can be distinguished, although often current-carrying ("hot") and "cold" instruments are used alternately. Postoperative pain seems to be uninfluenced by technique, whereas postoperative hemorrhage rates seem to be higher in "hot" techniques.
LigaSure® is a bipolar "current-carrying" device, which is able to seal vessels. Simultaneously tissue impedance is measured to control energy application. In this way only the required energy levels are applied. Therefore LigaSure® can also be referred as a "softened hot" technique.
In 2005 Lachanas et al. compared the LigaSure®-technique with the "cold" steel technique in 200 patients and found significantly less postoperative pain in favor of the LigaSure®-technique. Postoperative hemorrhage rates were not higher with LigaSure®. Based on the LigaSure®-scissors, Medtronic introduced a device specifically developed and licensed for tonsillectomies (BiZactTM).
Aim of this study will be the evaluation of handling, surgical time, postoperative pain and postoperative hemorrhage rates in comparison to traditional techniques on the contralateral side. In one patient, two different techniques will be used. This side-controlled evaluation of surgical techniques in tonsillectomies has been proven successfully in previous studies.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will not be informed which side was operated with the BiZact™ device. Surgeons however inevitably know side. The side will also be documented in the surgical report. Follow-up specialists must refrain from reading through surgical reports, thus not know which technique was used for which side. Discharging letters will not include technique information.
入排标准
- 年龄范围
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 and older
- •Written informed consent (in case of underage participant also parental informed consent)
- •Assigned for Tonsillectomy on both sides due to chronic tonsillitis
排除标准
- •History of abscesses in tonsillar region
- •Coagulation disorder (as assessed by a coagulation questionnaire and blood results)
- •Suspicion of untreated malignancy of any kind
- •Planned removal of only one tonsil
研究组 & 干预措施
BiZact™ device
BiZact™ device will be used appropriately to its purpose to remove one tonsil by:
- Incision of the anterior palatal arch
- Locating of the cranial pole of the tonsil
- Dissection of the tonsil capsule
- Localized coagulation of bleeding vessels
- Detaching of the inferior pole from the pharynx tissue
干预措施: BiZactTM Open Sealer/Divider (Device)
Cold steel dissection (CD)
Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).
干预措施: BiZactTM Open Sealer/Divider (Device)
结局指标
主要结局
surgical time
时间窗: 1 hour (intraoperative)
For the aim of the study surgical time is defined as time from superior mucosal incision to the moment when the removed tonsil is placed on instrument table (recorded by theatre staff - stopwatch).
次要结局
- Time to stop bleeding(1 hour (intraoperative))
- Postoperative pain assessment(Day of surgery until 2 months after surgery)
- Tonsil mobility intraoperatively(intraoperative)
- intraoperative blood loss(1 hour (intraoperative))
- Wound healing(approx. 10 days after surgery)
研究者
Assoc. Prof. PD Dr. Gregor Heiduschka
Assoc. Prof. PD M.D.
Medical University of Vienna