Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- recurrence of ovarian masses
研究概览
简要总结
Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.
Re-introduction of the ovary to inside the abdominal cavity:
The stitched ovary is pushed gently inside the abdominal cavity and the mini-laparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.
详细描述
Patient positioning and port placement:
Under general anaesthesia, the patient is placed in themodified dorsal lithotomy position (to ensure lax anterior abdominal wall). The patient is thenprepped and draped in the usual fashion for an abdominaland vaginal procedure. In non- virgin patients, vaginal speculum is inserted into thevagina to expose the cervix, a uterine manipulator is inserted in the cervix followed by placement of a Foley's catheter in thebladder. As regards port placement, a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •unilateral or bilateral ovarian cysts (≥ 10 cm),
- •recurrent ovarian cysts
- •good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml & antral follicular count {AFC} > 4)
排除标准
- •solid ovarian masses
- •patients who were unfit for surgery
- •chronic diseases (e.g. cardiac disease or diabetes)
- •any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)
结局指标
主要结局
recurrence of ovarian masses
时间窗: 6 months after the operation
recurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary
次要结局
- Serum antimullerian hormone(6 months after the operation)
- serum follicle stimulating hormone(6 months after the operation)
研究者
Ahmed M Maged, MD
professor
Cairo University