Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
Conditions
Cervical Cancer - Uterus Cancer - Ovarian Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
gynecology, oncology, coelioscopy, robot, morbidity
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gynecologic surgery - standard coelioscopy Type: Procedure
Name: gynecologic surgery - robot assisted coelioscopy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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 Criteria:

- metastatic disease

- pregnant or lactating woman

- patient unable to proceed follow-up visit, because of geographic, social or psychic reasons
Locations
CHU Bordeaux, Hôpital Saint-André
Bordeaux, France
Status: Recruiting
Contact: Vanessa CONRI, MD - +33(0)556795835 - vanessa.conri@chu-bordeaux.fr
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Status: Recruiting
Contact: Alain DELEST, MD - +33(0)556437311 - dr.delest@bordeauxnord.com
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Fabrice NARDUCCI, MD - +33(0)320295918 - f-narducci@o-lambret.fr
CHRU Lille, Hôpital Jeanne de Flandres
Lille, France
Status: Recruiting
Contact: Pierre COLLINET, MD - +33(0)320446388 - pierre.collinet@chru-lille.fr
CHU Limoges
Limoges, France
Status: Recruiting
Contact: Tristan GAUTHIER, MD - +33(0)555056164 - tristan.gauthier@chu-limoges.fr
Institut Paoli Calmette
Marseille, France
Status: Recruiting
Contact: Gilles HOUVENAEGHEL, MD - +33(0)491223333 - houvenag@marseille.fnclcc.fr
CHU Nîmes
Nimes, France
Status: Recruiting
Contact: Catherine FERRER, MD - +33(0)466683216 - catherine.ferrer@chu-nimes.fr
Polyclinique KenVal
Nimes, France
Status: Recruiting
Contact: Gregory TRIOPON, MD - 33 4 66 67 66 66 - gtriopon@hotmail.com
Hôpital Européen Georges Pompidou
Paris, France
Status: Recruiting
Contact: Fabrice LECURU, MD - +33(0)156093584 - fabrice.lecuru@egp.aphp.fr
Polyclinique Courlancy
Reims, France
Status: Recruiting
Contact: Stéphane URRUTIAGUER, MD - 33 3.26.77.27.55 - stephane.urrutiagger@free.fr
Centre hospitalier de Roubaix
Roubaix, France
Status: Recruiting
Contact: Ndaye MUBIAYI, MD - 03 20 99 32 16 - ndaye.mubiayi@ch-roubaix.fr
Institut de Cancérologie de l'Ouest Site René Gauducheau
St HERBLAIN, France
Status: Recruiting
Contact: J-Marc CLASSE, MD - 33 2.40.67.99.59 - jean-marc.classe@ico.unicancer.fr
CHU Rangueil
Toulouse, France
Status: Recruiting
Contact: Pierre LEGUEVAQUE, MD - +33(0)561323752 - leguevaque.p@chu-toulouse.fr
Institut Claudius Regaud
Toulouse, France
Status: Recruiting
Contact: Denis QUERLEU, MD - +33(0)561424157 - querleu.denis@claudiusregaud.fr
CHRU de Tours
Tours, France
Status: Recruiting
Contact: Thomas HEBERT, MD - 02 47 47 47 47 - t.hebert@chu-tours.fr
Centre Hospitalier de Valenciennes
Valenciennes, France
Status: Recruiting
Contact: Jérôme PHALIPPOU, MD - 03 27 14 01 30 - phalippou-j@ch-valenciennes.fr
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France
Status: Recruiting
Contact: François GUILLEMIN, MD - +33(0)383598451 - f.guillemin@nancy.fnclcc.fr
Start Date
December 2010
Completion Date
December 2016
Sponsors
Centre Oscar Lambret
Source
Centre Oscar Lambret
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page