Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of Cesarean Scar Diverticula
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- thickness of the remaining muscular layer (mm)
研究概览
简要总结
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Currently, several limited surgical management procedures for CSD have been reported, such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients are younger than
- •Clearly diagnosed with CSD.
- •Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
- •The thickness of the remaining muscular layer of CSD was less than 3 mm.
- •The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
- •The medicine conservative treatment is invalid.
- •Refusing or use birth control pills contraindications.
- •No serious medical problems (important viscera function in the normal range).
- •No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.
- •No gynaecology or other malignant tumors.
- •Sign the informed consent.
排除标准
- •Over the age of 40;
- •Indefinite diagnosis.
- •The absence of clinical manifestations of CSD.
- •The presence of menstrual irregularities before cesarean delivery.
- •Coagulation disorders.
- •Malignant tumors.
- •With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- •Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.
- •Use of intrauterine devices.
- •Unwilling to comply with the research plan.
结局指标
主要结局
thickness of the remaining muscular layer (mm)
时间窗: 6 months after surgery
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
次要结局
- duration of menstruation (day)(6 months after surgery)
- the width of CSD (mm)(6 months after surgery)
- the depth of CSD (mm)(6 months after surgery)
- the length of CSD (mm)(6 months after surgery)