Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy (ROBO-GYN)

• Perioperative morbidity at six months [ Time Frame: six months after surgery ] [ Designated as safety issue: Yes ]
  To estimate the rate of complications within the first six months after surgery, according to the Clavien-Dindo and NCI CTCAE-v4.0 grading scales
  
  

• Anesthesic and ventilator parameters [ Time Frame: every 30 min during the surgery ] [ Designated as safety issue: No ]
  Description of anesthesic and ventilator parameters
  
  
• Post-operative analgesia [ Time Frame: at 24h, 48h after sugery and until discharge ] [ Designated as safety issue: No ]
  collect of antalgic treatments
  
  
• Surgeon's ergonomy [ Time Frame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale) ] [ Designated as safety issue: No ]
  according to Borg and NASA-TLX scales
  
  
• Quality of Life [ Time Frame: until 2 years after surgery ] [ Designated as safety issue: No ]
  according to SF-36 questionnaire
  
  
• Description of surgical procedures [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  operative time (overall intervention, incision or "skin-to-skin", robot).
  
  
• Progression-free survival [ Time Frame: until 2 years after surgery ] [ Designated as safety issue: No ]
  delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death.
  
  
• Anatomopathology [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.
  
  

Laparoscopic surgery, also called minimally invasive surgery (MIS), is a surgical method less invasive than classical laparoscopic open procedure. Particularly, MIS is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.