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临床试验/NCT00636402
NCT00636402Unknown不适用

Vessel Sealing System Tonsillectomy vs Cold Knife Tonsillectomy: A Randomized, Paired Control Study of Efficacy and Adverse Effects

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Intra-operative time

研究概览

简要总结

This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.

详细描述

Tonsillectomy is one of the most common procedures performed by otolaryngologists. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain and hemorrhage.

The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma. This study was planned to compare vessel sealing system tonsillectomy (VSST) to the traditional cold knife tonsillectomy (CKT) with special regard to intraoperative bleeding, operative time, postoperative pain and hemorrhage.

Inclusion criteria are patients planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea and written informed consent form is given from patient or patient's parents (in case of pediatric patient).

Exclusion criteria are pregnancy, history of bleeding disorders, unilateral tonsillectomy, much different size of both tonsils (If the difference is more than or equal to 2, it will be defined as much different in size in this study), patient unable to understand evaluation method or unable to be contacted via telephone. Outcome measurements are the following.

  1. Operative time (minutes) will be started at the time of incision and ended at the time of complete hemostasis. After tonsillectomy on the first side is finished, 5-10 minutes is the lag time before tonsillectomy on the second side will be started in order to observe re-bleeding after operative time is recorded. If there is re-bleeding, the operative time will be changed and measured from the same starting time to the time of last complete hemostasis.
  2. Amount of blood loss (milliliter) will be measured from amount of fluid including blood and saliva in the container and gauze. Measurement will be started at the time of incision and ended at the time of complete hemostasis in the same manner of operative time.
  3. Pain score, postoperative hemorrhage or other adverse effects that the research assistant will record on post-op day 0-14 by using direct and telephone interview.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea
  • Written informed consent form is given from patient or patient's parents (in case of pediatric patient)

排除标准

  • Pregnancy
  • History of bleeding disorders
  • Unilateral tonsillectomy
  • Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study)
  • Patient unable to understand evaluation method
  • Patient unable to be contacted via telephone

结局指标

主要结局

Intra-operative time

时间窗: 1 day

Intra-operative blood loss

时间窗: 1 day

Pain, postoperative

时间窗: 14 days

次要结局

  • Postoperative bleeding and other adverse effects(14 days)

研究者

申办方类型
Other

研究点 (2)

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