Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- successful surgical procedure
研究概览
简要总结
laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects
详细描述
Laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
using sequentially numbered, opaque sealed enveloped; each envelope contains the method of intervention according to the random sequence and will be opened just before the intervention.
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PCOS according to Rotterdam Criteria (2 out of 3):
- •polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume >10 cm3).
- •oligo- or an-ovulation.
- •clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles.
- •Indications of laparoscopic ovarian drilling:
- •clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles.
- •other indications for laparoscopy.
- •before gonadotropin administration to decrease risk of OHSS and multiple pregnancy.
- •before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.
排除标准
- •previous 2 or more laparotomies.
- •chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain.
- •High BMI (>35kg/m2)
- •do not possess a native umbilicus.
- •advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy).
- •contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.
结局指标
主要结局
successful surgical procedure
时间窗: 1 hour (minutes)
without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).
次要结局
- intraoperative complications(1 hour)
- intraoperative blood loss(24 hour after end of procedure)
- cosmetic outcome(day 1 and day 7)
- operative time(1 hour (minutes))
- postoperative hospital stay(3 days)
- postoperative complications(1st week)
- postoperative pain(1st day)
研究者
Ahmed Mohamed Bahaa Eldin Ahmed
assistant professor
Ain Shams Maternity Hospital