NCT04788498Unknown不适用
Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 主要终点
- Postoperative pain
研究概览
简要总结
The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.
The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure
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
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients are aged 18 to 45 years with BMI < 35 kg/m2 and that they exhibit a surgical indication for a presumed benign ovarian pathology (PBOP) according to RCOG Guideline no.
- •simple ovarian cysts >7cm and <15cm.
- •Persistent simple cyst for more than 3 months.
- •Symptomatic patients with complicated cyst (e.g. hemorrhagic cyst, torsion, etc)
排除标准
- •• Previous midline laparotomies as suspected massive adhesions affecting intraoperative maneuvers and time.
- •Chronic pelvic pain, endometriosis or pelvic inflammatory diseases will be excluded to avoid pelvic adhesions and bias in the quantification of postoperative pain.
- •Do not possess a native umbilicus giving difficult access to single port.
- •The 'risk of malignancy index' (RMI) should be used to exclude those women at greater risk of malignancy. Using an RMI cut-off of 200, a sensitivity of 70% and specificity of 90% can be achieved. if features suggestive of malignancy are encountered, a gynecological oncologist should be consulted regarding further evaluation and staging.
- •Benign teratomas for the difficulty of extraction after removal that affects the intraoperative maneuvers and time.
- •Contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
- •Contraindication to general anesthesia as all laparoscopic procedures are done under GA.
- •Contraindication to non-steroidal anti-inflammatories, paracetamol, or tramadol.
结局指标
主要结局
Postoperative pain
时间窗: at 24 hours ± 2 hour after the intervention
The pain will be assessed by a numeric rating scale of 0-10
次要结局
- the need for conversion to laparotomy(intraoperative)
- Operative time(intraoperative)
- the need to add an additional trocar(intraoperative)
研究者
Mahmoud Nabil
Doctor
Ain Shams University
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