Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.
详细描述
The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.
Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.
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
- •Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).
排除标准
- •Women with:
- •known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
- •known neoplasia requiring pelvic lymphadenectomy
- •pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
- •conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
- •large uteri interfering with vaginal hysterectomy (size >16 gestational weeks)
结局指标
主要结局
Operative time
时间窗: duration of surgical procedure
Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.
次要结局
- Blood transfusion(24 hours post-operative)
- Surgical complications(intra-operative)
- Post-operative pain assessed using visual analogue scale for pain intensity(first 24 hours post-operative)
- Change in serum markers for inflammation(first 24 hours post-operative)
- Healthcare costs(1 week)
- Blood loss(intra-operative)
- Proportion of successful vaginal opportunistic salpingectomy(intra-operative)
- Febrile morbidity(first 24 hours post-operative)
- Hospital-stay(1 week)
研究者
Hamdy Bakry Alqenawy
Assistant Lecturer
Ain Shams University