Hysteroscopic Septoplasty by Different Modalities: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Operative and post operative complications
研究概览
简要总结
The goal of this clinical trial is to compare in participant population ( women with uterine septum meeting the inclusion criteria) hysteroscopic septoplasty by resectoscope compared to hysteroscopic septoplasty with scissors.
The main questions to answer are:
Is there a difference in operative time ? Is there a difference in fluid used and fluid deficit? Is there a difference in complications? Is there a difference in reproductive outcome? Researchers will compare the 2 different techniques to see if there is any difference in operative outcome ( operative time, fluid used and deficit, need for second intervention, and operative and postoperative complications) and reproductive outcome.
详细描述
Study design:
Prospective randomized clinical trial
Study duration and location:
For at least 24 months, Patients admitted to Obstetrics and Gynecology department at Mansoura University Hospital.
Study method
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age
- •Seeking conception
- •Diagnosis of a septate or subseptate uterus
- •A history of one of the following:
- •Recurrent pregnancy loss
- •Subfertility
- •Preterm Birth
排除标准
- •Not seeking conception
- •Diagnosis of septate or subseptate uterus with no history of any of the following:
- •Recurrent pregnancy loss
- •Subfertility
- •Preterm Birth
- •Contraindications for surgery
- •Those who refused to participate.
研究组 & 干预措施
Scissors arm
Patients in this group had undergone resection of the septum with hysteroscope and scissors, The scissors used was pointed, single action and semi rigid . Saline was used as the distending medium in the scissors group. Septal incision was carried out using shortening technique by incising the septum at the leading edge and continue dividing by moving from side to side (in narrow septum), or by thinning technique by which incisions will be made along each side of the septum alternately from one cornual end to the other (in broad septum). The operation was stopped if the fluid deficit exceeded 2500 ml of saline.
干预措施: Hysteroscopic septoplasty with scissors (Procedure)
Resectoscope arm
Patients in this group had undergone resection of the septum with Monopolar 26 French resectoscope Dilation of cervical os with Hegar's dilator (up to hegar 8 or 9) , incision of the septum using a resectoscope with the Collins knife, monopolar energy (cut 40-70 Watt) and glycine 1.5% as the distension medium, using shortening or thinning incision. The operation was stopped if the fluid deficit exceeded 1000 ml of glycine. The delivery of distension media was conducted by automated pressure delivery system. All patients were prescribed cyclic estrogen and progesterone for two months.
干预措施: Hysteroscopic septoplasty with resectoscope (Procedure)
结局指标
主要结局
Operative and post operative complications
时间窗: 3 months follow up after intervention
Operative time
时间窗: During surgery
Need for second intervention
时间窗: 3 months follow up after intervention
Fluid deficit
时间窗: During surgery
次要结局
- Pregnancy rate(At least 6 months follow up after intervention)
- Live birth rate(Follow up until the end of first clinical pregnancy or 6 months after surgery)
研究者
Ahmed Moustafa Alsayed Alamely
Assistant lecturer of Obstetrics and Gynecology
Mansoura University Hospital