Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
试验速览
- 阶段
- 3 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Estimated intra-operative blood loss measured in milliliters
研究概览
简要总结
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
详细描述
this study aims at comparing between different methods to decrease blood loss in trans-abdominal myomectomy. this study compares between medical (intravenous tranexamic acid administration) and non medical (pericervical tourniquet) methods in decreasing blood loss intra operative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Women in the reproductive age (20 - 40 years) diagnosed as having uterine fibroids who are consenting to have trans-abdominal myomectomy in the postmenstrual period diagnosed by:
- •Clinical symptoms and signs:
- •Abnormal uterine bleeding (menorrhagia or (and) metrorrhagia).
- •Pain (dull aching lower abdominal pain or dysmenorrhea).
- •Pressure symptoms (dyspareunia, dysuria, dyschezia or (and) backache).
- •Progressive abdominal enlargement (abdominal swelling).
- •All women with clinical presentation suggestive of uterine fibroid will undergo abdominal and trans-vaginal ultrasound to confirm the clinical diagnosis and to exclude patients with:
- •Submucous uterine myomas.
- •Cervical or supracervical myomas.
- •Broad ligamentary and pedunculated myomas.
- •Associated pelvic pathology.
- •Ultrasound criteria of uterine fibroids of included patients:
- •Maximum diameter of the largest fibroid is greater than 4cm.
- •Maximum number of uterine myomas is not to be more than 5 myomas.
- •Uterine fibroid may be subserous or intramural.
排除标准
- •Obesity (body mass index >30 kg/m2).
- •Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl).
- •Patients known to be allergic to tranexamic acid.
- •Patients who received pre-operative hormonal therapy (such as a GnRH analogue).
- •Patients presented by or with suspected malignant gynecological disease.
- •Patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids.
- •Patients with contraindication to general anaesthesia.
- •Patients with positive pregnancy test.
- •Virgin patients.
研究组 & 干预措施
Pericervical Tourniquet
The tourniquet method will be used where the urinary bladder will be dissected downwards from the lower uterine segment, and then a perforation will be made in the posterior leaflet of the broad ligament bilaterally at the level of uterine isthmus. A tourniquet (using 16- inch Foley catheter) will be passed through the perforation encircling the uterine arteries bilaterally. The Fallopian tubes and the ovaries will be carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet will be released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus
干预措施: Pericervical Tourniquet (Procedure)
tranexamic acid
bolus intravenous injection of tranexamic acid 10mg/kg (maximum1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1L of saline for 10 h (maximum
1 g/10 h)
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Estimated intra-operative blood loss measured in milliliters
时间窗: first 24 hours postoperative
次要结局
- The need for intra-operative blood transfusion(1 hour)
- The need for conversion from myomectomy to hysterectomy(1 hour)
- Operative time in minutes(1 hour)
- Intra-operative or post-operative complications(24 hours)
- Difference between Pre and post-operative hemoglobin and hematocrit levels(24 hours)
- Duration of hospital stay in days(7 days)
研究者
Ahmed Mohamed Bahaa Eldin Ahmed
Clinical professor
Ain Shams Maternity Hospital