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临床试验/NCT06343493
NCT06343493已完成不适用

Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery: A Randomized Controlled Trial

Rawalpindi Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月16日最近更新:
适应症
干预措施
相关药物

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
1
主要终点
Boezaart Score

研究概览

简要总结

Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.

This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.

KEY WORDS:

  • Chronic rhinosinusitis (CRS)
  • Endoscopic sinus surgery
  • Boezaart score

详细描述

INTRODUCTION: Chronic rhinosinsusitis is an inflammatory disease of the sinonasal mucosa lasting for more than 12 weeks. Endoscopic sinus surgery is the surgical procedure used to treat recalcitrant chronic rhinosinusitis. It not only helps in the drainage of sinuses and removal of pathology but also prevents the disturbance of anatomy and formation of facial scars. Control of bleeding during the procedure is a test for surgeons as well as anesthetists. Capillaries are the commonest vessels to bleed during the surgery so that's why mean arterial pressure is an important determinant of the severity of bleeding. A good control of bleeding gives a good visualization of the anatomy during the procedure.

There are different ways to reduce bleeding but all carry side effects too. Topical vasoconstrictors may also be absorbed systemically so must be used carefully in children and patients with cardiac ischemia. Moreover, there's no accurate way to measure absorption of a vasoconstrictor so it's difficult to recommend a safe dose for a particular patient. Cautery which is used to seal blood vessels is also associated with pain as well as mucosal damage. Anesthesia induced hypotension is also not appropriate for all patients as it results in decreased oxygen supply to various vitals organs of the body.

Normal saline heated up to 50°C causes dilatation of vessels and nasal edema without causing nasal mucosa necrosis. This edema compresses blood vessels and helps in controlling bleeding. It also promotes the clotting cascade. In addition, it provides better visualization of the surgical field by reduction of fog formation. A study conducted by Shehata A et al. showed a significant improvement in the operative field when normal saline at 50° C was used during endoscopic sinus surgery. Not only the operative filed was improved, also the duration of surgery was significantly reduced. According to the results of this study, saline heated up to 50°C used for the irrigation of endoscopic sinus surgery produced a result comparable to usage of tranexamic acid with a significant p value. Another study by Ranford D et al. concluded that irrigation with heated saline during endoscopic sinus surgery reduced bleeding by 20 percent.

This study aims to assess the effect of heated normal saline up to 50°C upon the operative field during endoscopic sinus surgery. The use of hot saline for irrigation during endoscopic sinus surgery can prove to be a cost effective method to have a bloodless field during surgery.

METHODS AND MATERIALS:

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, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with chronic rhinosinusitis requiring surgery

排除标准

  • Unilateral disease
  • Suspicion of malignancy
  • Bleeding diathesis
  • Significant comorbidities

研究组 & 干预措施

Group A (Interventional Group)

Experimental

Hot saline with a temperature of 50°C used for irrigation during endoscopic sinus surgery. Frequency of the drug is according to the operative field and surgeon's need.

干预措施: Normal saline heated up to 50 °C (Drug)

结局指标

主要结局

Boezaart Score

时间窗: Per operative

Operative field is assessed based on the Boezaart score which is a subjective score graded from 0 to 5 where 0 shows no bleeding and is the minimum score. 5 is the maximum score which shows severe bleeding. So the outcome worsens as the grade becomes higher from 0 to 5. 5 shows the worst outcome.

次要结局

  • Bleeding in ml(Per operative)
  • Duration of Surgery(From the start of surgery to the end (per operative))

研究者

发起方
Rawalpindi Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

JAWAIRIA ALTAF

Postgraduate trainee ENT

Rawalpindi Medical College

研究点 (1)

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