Status:
COMPLETED
Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
National Cancer Institute, France
Conditions:
Cervical Cancer
Uterus Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 gynec...
Eligibility Criteria
Inclusion
- patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification
- patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification
- patient with cervical cancer depending on a restadification
- patient aged over 18 years
- previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion
- WHO score equal or inferior to 3
- cirrhosis-related Child-Pugh score under or equal to A7 are allowed
- life expectancy equal or superior to 12 weeks
- patient affiliated to health insurance
- dated and signed informed consent
Exclusion
- metastatic disease
- pregnant or breastfeeding woman
- patient unable to proceed follow-up visit, because of geographic, social or mental reasons
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT01247779
Start Date
December 1 2010
End Date
November 1 2017
Last Update
March 8 2019
Active Locations (17)
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1
CHU Bordeaux, Hôpital Saint-André
Bordeaux, France, 33300
2
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
3
Centre Oscar Lambret
Lille, France, 59000
4
CHRU Lille, Hôpital Jeanne de Flandres
Lille, France, 59037