Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.
详细描述
According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.
In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Symptomatic apical descent stage II or more.
- •Eligible for both surgical procedures
- •No uterine or cervical pathology.
- •Able to consent to participate in the trial.
排除标准
- •Women with contraindication to any surgical procedures.
- •Women with previous apical prolapse surgery.
- •One of the two surgical approaches is not feasible.
- •Women with concomitant surgical procedures apart from correction of the prolapse.
- •Women who prefer to have hysterectomy.
研究组 & 干预措施
Abdominal sacral hysteropexy
The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.
干预措施: Hysteropexy (Procedure)
Vaginal sacrospinous hysteropexy
This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion.
The outcomes will be obtained as follow;
干预措施: Hysteropexy (Procedure)
结局指标
主要结局
Operative time
时间窗: intraoperative
Operative time will be recorded starting from skin incision.
次要结局
- a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).(From 6 months to 1 year follow up)
- b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0(From 6 months to 1 year follow up)
研究者
Mohamed Hassan Mohamed Mostafa
Doctor
Ain Shams University