French Prospective Clinical Database of Colorectal Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,800
- 试验地点
- 4
- 主要终点
- Collection of clinical data following surgery with robotic assistance in colorectal pathologies
研究概览
简要总结
Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.
详细描述
Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.
Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.
But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.
3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.
No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years
- •Colorectal pathologies (Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Colorectal tumor, Rectal prolapse, Benign and colorectal tumor) eligible for robotic surgery.
- •Major techniques: right and left colectomy, rectal excision (low anterior resection, intersphincteric resection, abdominoperineal resection), Hartman reversal
- •Or, Minor techniques: rectopexy, shaving for rectal endometriosis,
- •Or, Complex techniques: extended rectal excision for T4 cancer, pelvectomy, redo surgery.
- •Patient affiliated to a social security regimen
- •Patient information for study
排除标准
- •Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
- •Patient under tutelage, curatorship or safeguard of justice
结局指标
主要结局
Collection of clinical data following surgery with robotic assistance in colorectal pathologies
时间窗: 3 years
次要结局
- Urinary functionality by using the questionnaire of urinary function(3 years)
- Number of lymph node resected(3 years)
- Operating time(3 years)
- The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score(3 years)
- Quality of the mesorectum by using Quirke classification(3 years)
- Intraoperative complications rate(3 years)
- local relapse-free survival(8 years)
- Time of learning for each surgical technique by determining a learning curve for each of them(3 years)
- The conversion rate of surgical technique(3 years)
- Duration of hospital stay(1 month)
- overall survival(8 years)
- Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS)(3 years)
- The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function)(3 years)
- Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System(3 years)