Evaluation of Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often a cause of significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia and chronic pelvic pain) and infertility, drastically reducing patients' quality of life.
Surgical therapy with complete removal of endometriotic lesions is often necessary when the disease is resistant to medical therapy.
The minimally invasive surgical approach has proved to be the most advantageous.
Over time, there has been a growing use in the gynecological field of robot-assisted laparoscopic surgery.
Several clinical cases and retrospective studies on robotic surgery for DIE have highlighted favorable surgical outcomes, with the exception of operative times, compared to standard laparoscopic approach.
However, a randomized control studies comparing surgical outcomes and postoperative pelvic organs function in women with DIE submitted to robotic-assisted or conventional laparoscopy is missing.
In order to analyze the real impact of robotic advances the present study sought to assess surgical outcomes and urinary, bowel and sexual functions in women with DIE requiring minimally invasive surgery through robot-assisted or conventional lps approach.
详细描述
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Patients are divided into 2 groups:
Group A: standard laparoscopic approach
Group B: robot-assisted approach
After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.
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
- •Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance
- •Patients with indication for removal of endometriosic lesions by standard and robot-assisted laparoscopy
- •Obtaining Informed Consent
排除标准
- •Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
- •Cardiovascular problems
- •Hepatic insufficiency
- •Psychiatric diseases
- •History of oncologic disease
结局指标
主要结局
Operative time
时间窗: Intraoperative
Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery
次要结局
- Length of hospitalization(Up to 4 days: from the date of surgery until the last day of hospitalization)
- Laparotomic conversion rate(Intraoperative)
- Complication rate(up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months)
- Evaluation of sexual function(up to three months after surgery)
- Evaluation of urinary symptoms(up to three months after surgery)
- Change of haemoglobin levels(24 hours after surgery)
- Evaluation of bowel symptoms(up to three months after surgery)
- Evaluation of disease recurrence rate(Up to 12 months after surgery; from date of surgery until the date of first clinical or trans-vaginal/abdominal ultrasound documented recurrence, assessed up to 12 months)
研究者
Renato Seracchioli
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna