Effect of Topical Tranexamic Acid Spray Versus No Spray on Postoperative Seroma and Wound-Related Outcomes Following Mesh Repair of Umbilical Hernia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Rate of Postoperative Seroma
研究概览
简要总结
Umbilical hernia is a type of ventral hernia that occurs commonly in adulthood, and mesh reinforcement is well established since there is a reduced recurrence rate when compared to suture repair. However, the repair of meshes could prove to be complex due to seroma, hematoma, wound infection, pain, and other surgical-site events.3 Seroma formation is considered clinically significant due to its ability to be painful, recurrent outpatient care, aspiration, infection, and slow wound healing.
详细描述
Surgical techniques that minimize bleeding and postoperative perioperative fluid build-up can thus enhance hernia repair recovery. Tranexamic acid is a man-made lysine analogue which prevents fibrinolysis and has undergone extensive research in reducing perioperative bleeding. Topical use has a high level of local antifibrinolytic activity and minimal systemic exposure and has demonstrated a decrease in blood loss and drainage in a variety of surgical specialties. Current randomized trials in breast and reconstructive surgery have shown variable findings on the prevention of seroma and hematoma, with a few showing reduced volumes of drainage or fluid complications. Present meta-analyses are also in favour of topical tranexamic acid to minimise the blood loss but also highlight the heterogeneity across procedures
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years.
- •Either gender.
- •Patient has primary umbilical hernia.
- •To have elective umbilical hernia open meshes repair planned.
- •Hernia defect that can be repaired with the help of the standardized mesh technique that was used in the study.
- •ASA physical status I-III.
- •No acute infection in or about the site of operations.
- •Able to provide written informed consent
排除标准
- •• Emergency with incarcerated, obstructed, or strangulated umbilical hernia.
- •Frequent umbilical or ventral hernia.
- •Major abdominal surgery scheduled concomitants on the same surgery.
- •Active local or systemic infection.
- •Hypersensitivity known to tranexamic acid.
- •History or current deep-vein thrombosis or pulmonary embolism or other thromboembolic hemorrhagic disease.
- •Known inherited/acquired thrombophilia.
- •Greater renal impairment that needed to be avoided or have its dosage increased significantly with tranexamic acid.
- •History of seizures/ epilepsy where tranexamic acid is inappropriate.
- •The presence of currently used therapeutic anticoagulation which may not be controlled accordingly during operation.
- •Coagulopathy or known bleeding.
- •Pregnancy or breastfeeding.
- •Patients who need a significantly different operative or mesh method intraoperative
研究组 & 干预措施
Topical Tranexamic Acid Spray
干预措施: Topical Tranexamic Acid Spray (Drug)
No Topical Tranexamic Acid Spray
干预措施: No Topical Tranexamic acid (Drug)
结局指标
主要结局
Rate of Postoperative Seroma
时间窗: 30 days
A post procedural presence of pale or clear, straw-colored swelling on the site of a surgery that occurred or happened within 30 days since the operation and has been identified clinically and had to be confirmed by the ultrasonographic method, in case of uncertainty
Rate of Postoperative Hematoma
时间窗: 30 days
It is a localized pool of blood or clot at the operative site that occurs in the clinically and or ultrasonographically-it can be detected within 30 days after surgery.
次要结局
未报告次要终点
研究者
Dr Mudassar Saeed Pansota
Dr Mudassar Saeed
Shahida Islam Medical Complex