A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Hospital stay
研究概览
简要总结
Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced
The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain
详细描述
Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.
The study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.
This randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years
- •Able to give informed consent
- •must have two of the following three:
- •systolic blood pressure >90 mmHg
- •pulse rate <100 beats per minute
- •heamoglobin >8 g/dL
排除标准
- •<18 years
- •haemodynamically unstable
- •not able to give informed consent
结局指标
主要结局
Hospital stay
时间窗: 5 days
Hospital stay will be compared between the two groups
次要结局
- Pain scores(24 hours)
- Theatre time(1 day)
研究者
Leon Snyman
Professor
University of Pretoria