Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- intraoperative bleeding
研究概览
简要总结
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .
详细描述
This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
- •grade 0 and grade 1 submucous myomas
- •less than 5 centimeters in diameter
排除标准
- •Patients with grade 2 submucous myoma or more
- •patients with submucous myomas larger than 5 cm in diameter
- •postmenopausal women
- •patients received GnRh analogue in last 6 months
- •patients with anticoagulant therapy
- •patients with endometrial premalignant or malignant pathologies
- •patients with cardiovascular diseases, asthma or impaired kidney functions
研究组 & 干预措施
misoprostol group
20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
干预措施: Misoprostol (Drug)
vasopressin group
20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
干预措施: Vasopressin (Drug)
结局指标
主要结局
intraoperative bleeding
时间窗: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
subjective assessment of bleeding by the surgeon.
operative time
时间窗: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
time needed for completion of myomectomy procedure
haemoglobin and hematocrit deficit
时间窗: 24 hours before myomectomy and 24 hour after myomectomy
haemoglobin and hematocrit values before and after myomectomy
次要结局
- Fluid deficit(start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure)
- Degree of visual clarity(start with the first resectoscope myoma cut till the completion of myoma resection)
- time need for cervical dilatation(start from grasping the cervix till insertion of hysterescope)
研究者
Hossam mohamed
clinical investigator
Zagazig University