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临床试验/NCT07095647
NCT07095647已完成不适用

Surgical Outcomes of Simultaneous Hysteroscopy/Laparoscopy for Cesarean-Section Niche Ectopic Pregnancy Management and Uterine Niche Repair

Benha University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.

研究概览

简要总结

The study investigates the feasibility, safety, and outcomes of a simultaneous surgical approach for cesarean scar ectopic pregnancy (CSEP). CSEP is a prevalent and serious form of ectopic pregnancy requiring swift intervention. The research explores using hysteroscopy and laparoscopy concurrently to manage the CSEP and repair the uterine scar defect. The procedure involved hysteroscopic-guided evacuation and a double-layer laparoscopic repair, followed by a second hysteroscopy to confirm the repair's effectiveness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with positive clinical and lab pregnancy diagnosis;
  • Patients with history of at least one previous Cesarean section;
  • Patients with Transvaginal ultrasound documenting Cesarean scar ectopic Pregnancy;

排除标准

  • Patients with were extensive adhesions between the mass and the urinary bladder on MRI;
  • Patients with myomas, polyps, endometrial hyperplasia, and cancers of the cervix or endometrium;
  • Patients with a body mass index (BMI) of >35kg/m2;
  • Patients with previous abdominal surgeries with possible difficulties during laparoscopy;
  • Patients with menstrual irregularities, or coagulation disorders.

结局指标

主要结局

Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.

时间窗: 6~7 months

The proportion of patients who restored their normal endometrial metrics and removed any uterine scars during the study, reflecting the effectiveness of the applied Hystreoscopy regimens.

Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.

时间窗: 6~7 months

The proportion of patients who restored their normal endometrial metrics and removed any uterine scars during the study, reflecting the effectiveness of the applied Hystreoscopy regimens.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Naguib

Lecturer of Obstetrics & Gynecology, Faculty of Medicine

Benha University

研究点 (2)

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