Prospective Randomized Trial on 2D Versus 3D Laparoscopic Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Operative time for laparoscopic total hysterectomy with pelvic lymphadenectomy
研究概览
简要总结
This prospective randomized pilot study is aimed to verify if the operative time of a total laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy
详细描述
The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures include washing for cytology, total extrafascial hysterectomy and bilateral salpinges-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic lymphadenectomy is debated, staging information is a critical determinant of adjuvant therapy for most gynecologic oncologists.
Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are positive lymph nodes, those around the obturator nerve and around the external and common iliac vessels are more likely to be involved than those in the presacral area. Isolated involvement of the para-aortic nodes is rare. Complete excision of the nodes located around the iliac vessels and above the obturator nerve allows identification of 90% of node-positive patients.
The decision on whether to undertake lymphadenectomy should not be based on palpation of the nodal area, because less than 10% of patients with nodal metastases have grossly enlarged nodes.
Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3 endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph nodes. In our current treatment protocol, these patients undergo complete pelvic lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal infiltration.
Although the complication rate of a simple hysterectomy with bilateral salpinges-oophorectomy is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal women, commonly associated with medical co-morbidities, such as diabetes, hypertension and obesity. Abdominal surgery therefore exposes them to an increased risk of complications. Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery for these patients, but this approach does not allow exploration of the abdominal cavity, peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy overcome the previous limitations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age ≤ 75 years
- •Patient's informed consent
- •American Society of Anesthesiologists: < class III or IV
- •No actual pregnancies or P.I.D.
- •No previous major abdominal surgical procedures
- •Endometrial cancer FIGO stages IB-II
- •Endometrioid histotype
- •No previous radiotherapy on pelvic fields
- •No uterine size larger than conform 10 weeks gestation
研究组 & 干预措施
3D Laparoscopy
Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology.
A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition 3D telescope. Two additional 5 mm ports are placed under direct visualization. One more 5- mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system
干预措施: 3D Laparoscopy (Procedure)
Standard Laparoscopy
Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with standard laparoscopy technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope. Two additional 5 mm ports are placed under direct visualization. One more 5 mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.
干预措施: Standard Laparoscopy (Procedure)
结局指标
主要结局
Operative time for laparoscopic total hysterectomy with pelvic lymphadenectomy
时间窗: intraoperative
Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses
次要结局
- number of participants with intra or post operative complications(two years)
研究者
Prof. Giovanni Scambia
Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente
Catholic University of the Sacred Heart