Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Intermenstrual bleeding reduction (days)
研究概览
简要总结
The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
详细描述
Cesarean section, the most widely performed surgical procedure globally, has seen a significant increase in rates over the past decades, rising from 12.1% in 2000 to 21% in 2015 for various reasons. A recognized complication of cesarean sections is the formation of a uterine niche, commonly referred to as isthmocele. However, the true incidence of this post-operative complication remains uncertain, with reported figures ranging widely from 7% to 80%. The considerable variability in these estimates is attributed in part to the varying sensitivity of diagnostic tools. Moreover, there is a lack of consensus in the literature regarding the definition of a cesarean niche, particularly concerning the dimensions of the defect.
Recent well-designed randomized controlled trials have investigated the long-term outcomes of single versus double-layer hysterotomy closure during C-sections. These studies found no significant differences in isthmocele incidence or intermenstrual spotting. However, limitations such as the lack of correlation between symptom severity and uterine defect dimensions, the inclusion of women in labor, and relatively short follow-up periods are acknowledged weaknesses, prompting the need for further analysis.
Our objective is to compare the outcomes of single versus double-layer hysterotomy closure in terms of intermenstrual spotting and isthmocele incidence in singleton women undergoing elective C-sections. Crucially, standardizing the surgical suturing technique is essential to mitigate potential misleading outcomes resulting from inter-operator variations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Patients are recruited and randomly assigned to either the "single-layer" or "double-layer" arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous
- •singleton
- •age 18-45
- •spontaneous pregnancy or autologous assisted fertilization
- •gestational age 38-40 weeks
- •elective C-section
- •informed consent
排除标准
- •coagulopathy
- •autoimmune diseases
- •gestational diabetes
- •anticoagulant therapy
- •immunosuppressive therapy
- •endometriosis
- •uterine fibromatosis
- •spontaneous labour
- •connective tissue diseases
结局指标
主要结局
Intermenstrual bleeding reduction (days)
时间窗: 6 months
The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients.
次要结局
- Intra-operatory time(6 months)
- Post-operatory recovery time(6 months)
- Time to full patient mobilization(6 months)
- Isthmocele(6 months)
- Blood loss(6 months)
- Analgesics(6 months)
