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临床试验/NCT01717274
NCT01717274已完成不适用

Hot Saline Irrigation vs Room Temperature Saline Irrigation in the Control of Intraoperative Bleeding During Functional Endoscopic Sinus Surgery (FESS)

St. Paul's Hospital, Canada2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The Boezaart and van der Merwe intraoperative surgical field scale

研究概览

简要总结

Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow for the best surgical view and to reduce risk while in surgery.

Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body. The investigators would like to determine if hot saline irrigation (HSI) compared to room temperature saline irrigation (RTSI) can control bleeding during FESS.

The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding during FESS.

详细描述

Background and Significance:

Functional endoscopic sinus surgery (FESS) is a minimally invasive surgery to relieve obstruction and to facilitate drainage and ventilation of the paranasal sinuses. It is a common rhinologic procedure that is safe, comfortable and allows quick patient recovery. As the paranasal sinuses have complex anatomy and are surrounded by important structures, there are risks of serious orbital and intracranial injuries. These risks are increased if visualization during surgery is impaired with bleeding. The endoscopically magnified operative field in sinus surgery makes even a small amount of bleeding a potentially significant hindrance. Hence, numerous methods to reduce intraoperative bleeding during FESS have been described. These include the use of preoperative nasal decongestion (such as topical oxymetazoline, cocaine and adrenaline), preoperative oral tranexamic acid, intraoperative injection of the lateral nasal wall with lidocaine and adrenaline and intraoperative controlled hypotension (using total intravenous anaesthesia and B-blockers) as well as the head up position during surgery. The success rates of these methods have been variable and some of these techniques are associated with adverse cardiopulmonary events.1-7 Visual compromise secondary to bleeding remains a problem during FESS and the ideal method to reduce intraoperative bleeding remains elusive.

Hot water irrigation (HWI) was first used by obstetricians in controlling postpartum bleeding over a hundred years ago.8 Its use in the control of intractable epistaxis was first described by Guice in 1878.9 In a histological study of nasal mucosa of rabbits irrigated with hot water, Stangerup and Thomsen found that temperatures of up to 50 degrees Celsius produces vasodilation and edema of the nasal mucosa without necrosis. They postulated that mucosal edema leads to compression of the bleeding vessels and may trigger and accelerate the clotting cascade.10 Stangerup et al found that in their series of 122 patients, posterior epistaxis was controlled in 55% of patients treated with HWI compared to 44% in the group treated with nasal packing.11 Novoa and Schlegel-Wagner subsequently showed that 82% of patients with intractable posterior epistaxis can be arrested with HWI.12 HWI has also led to reduced hospital stay, reduced number of surgical procedures, less pain and less nasal trauma. As continuous exposure of the nasal mucosa to pure water for 30 minutes has been shown by an in-vitro study to cause severe damage to the epithelial cells, we have decided to use hot normal saline in our study.13 Although hot saline irrigation (HSI) has been used in FESS and endoscopic skull base surgery, there are currently no reports in the English literature on its effectiveness.

Aim:

To assess the effectiveness of hot saline irrigation (HSI) compared to room temperature saline irrigation (RTSI) in the control of intraoperative bleeding during FESS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with American Society of Anesthesiologist (ASA) classification <2
  • Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis refractory to medical treatment

排除标准

  • Patients with a history of coagulation disorders
  • Patients with severe ischemic heart disease (IHD), pulmonary and renal disease
  • Patients with tumours or vascular anomalies
  • Patients with cystic fibrosis, allergic fungal sinusitis and Wegener's granulomatosis
  • Patients who are unable to speak, read and write English

结局指标

主要结局

The Boezaart and van der Merwe intraoperative surgical field scale

时间窗: Every 15 minutes for the duration of surgery..

The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed

次要结局

  • Total Estimated Blood Loss(Duration of surgery)

研究者

发起方
St. Paul's Hospital, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Javer

Principal Investigator

St. Paul's Hospital, Canada

研究点 (2)

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