Effectiveness of Topical Tranexamic Acid in Reducing Intraoperative and Postoperative Bleeding Following Nasal Endoscopic Sinus Surgery: Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1. To assess the effectiveness of topical tranexamic acid in reducing intraoperative bleeding and immediate post op bleeding in patients undergoing endoscopic sinus surgery.
研究概览
简要总结
This research outlines the design and methodology of a randomized controlled trial aimed at assessing the impact of topical tranexamic acid application preoperatively on bleeding outcomes during surgery, surgical field visibility, operative time, and postoperative complications in patients undergoing nasal endoscopic sinus surgery. Secondarily, it also seeks to resolve discrepancies between various studies related to the use of topical tranexamic acid intraoperatively and postoperatively. Patients fulfilling the inclusion criteria will be recruited and divided into two distinct groups: a control group and a test group. The test group will be given topical tranexamic acid in their nasal packs preoperatively and postoperatively, after which intraoperative and postoperative assessments will be conducted , similarly for control group standard practice will be performed and their intraoperative and postoperative bleeding will be assed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of 18 years and above requiring endoscopic sinus surgery.
- •Patients aged 18 and above attending ENT OPD in AVMC with conditions such as chronic rhinosinusitis with or without polyp , Antrochoanal polyp, nasal diseases requiring unilateral or bilateral endoscopic sinus surgery scheduled for nasal endoscopic sinus surgery.
排除标准
- •Known allergy to tranexamic acid.
- •History of thromboembolic events, Coagulopathy, or use of anticoagulant medications.
- •Significant medical comorbidities (e.g., cardiovascular diseases, renal Impairment, with uncontrolled Diabetes and Hypertension).
- •Patients being operated for nasal tumour
- •Revision endoscopic nasal surgery.
结局指标
主要结局
1. To assess the effectiveness of topical tranexamic acid in reducing intraoperative bleeding and immediate post op bleeding in patients undergoing endoscopic sinus surgery.
时间窗: Intra operative checked at | 5 mins | 15 mins | 25 mins | 35 mins | post operatively checked at | Immediate post operatively | 6hrs post operatively | 12 hrs post operatively | 24 hrs post operatively
2. To assess the intra operative surgical field using Boezarts scale in both TXA group and control group in Endoscopic Sinus Surgery.
时间窗: Intra operative checked at | 5 mins | 15 mins | 25 mins | 35 mins | post operatively checked at | Immediate post operatively | 6hrs post operatively | 12 hrs post operatively | 24 hrs post operatively
次要结局
- 1. To detect the duration of surgery in both the groups(1. To detect the duration of surgery in both the groups ( noting time from start of surgery to the end ))
研究者
Bhairavi Sharma
Aarupadai Veedu Medical College and Hospital