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Brief Title: Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
Official Title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
Study ID: NCT01247779
Brief Summary: The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
CHU Bordeaux, Hôpital Saint-André, Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
CHRU Lille, Hôpital Jeanne de Flandres, Lille, , France
CHU Limoges, Limoges, , France
Institut Paoli Calmette, Marseille, , France
CHU Nîmes, Nimes, , France
Polyclinique KenVal, Nimes, , France
Hôpital Européen Georges Pompidou, Paris, , France
Polyclinique Courlancy, Reims, , France
Centre hospitalier de Roubaix, Roubaix, , France
Institut de Cancérologie de l'Ouest Site René Gauducheau, St HERBLAIN, , France
Institut Claudius Regaud, Toulouse, , France
CHU Rangueil, Toulouse, , France
CHRU de Tours, Tours, , France
Centre Hospitalier de Valenciennes, Valenciennes, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Name: Fabrice NARDUCCI, MD
Affiliation: Centre Oscar Lambret, Lille
Role: PRINCIPAL_INVESTIGATOR
Name: Eric LAMBAUDIE, MD
Affiliation: Institut Paoli-Calmettes
Role: STUDY_DIRECTOR