Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy - Full Text View

Purpose

The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

Condition	Intervention	Phase
Cervical Cancer Uterus Cancer Ovarian Cancer	Procedure: gynecologic surgery - standard coelioscopy Procedure: gynecologic surgery - robot assisted coelioscopy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 hours 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.


Estimated Enrollment:	374
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard Coelioscopy	Procedure: gynecologic surgery - standard coelioscopy lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
Experimental: Robot-assisted coelioscopy	Procedure: gynecologic surgery - robot assisted coelioscopy lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247779

Contacts


Contact: Fabrice NARDUCCI, MD	+33(0)320295918	f-narducci@o-lambret.fr
Contact: Yvette VENDEL, sponsor CRA	+33(0)320295940	y-vendel@o-lambret.fr

Locations


France
CHU Bordeaux, Hôpital Saint-André	Recruiting
Bordeaux, France, 33300
Contact: Vanessa CONRI, MD +33(0)556795835 vanessa.conri@chu-bordeaux.fr
Sub-Investigator: Claude HOCKE, MD
Sub-Investigator: Alice QUINART, MD
Sub-Investigator: Michel MADRAS, MD
Sub-Investigator: Jean-Luc BRUN, MD, PhD
Principal Investigator: Vanessa CONRI, MD
Polyclinique Bordeaux Nord Aquitaine	Recruiting
Bordeaux, France, 33300
Contact: Alain DELEST, MD +33(0)556437311 dr.delest@bordeauxnord.com
Sub-Investigator: Amélie PAUTE, MD
Sub-Investigator: Paynayotis CONSTANTOPOULOS, MD
Sub-Investigator: Gilles GIOANNI, MD
Principal Investigator: Alain DELEST, MD
Centre Oscar Lambret	Recruiting
Lille, France, 59000
Contact: Fabrice NARDUCCI, MD +33(0)320295918 f-narducci@o-lambret.fr
Contact: Yvette VENDEL, CRA +33(0)320295940 y-vendel@o-lambret.fr
Sub-Investigator: Eric LEBLANC, MD
Principal Investigator: Fabrice NARDUCCI, MD
CHRU Lille, Hôpital Jeanne de Flandres	Recruiting
Lille, France, 59037
Contact: Pierre COLLINET, MD +33(0)320446388 pierre.collinet@chru-lille.fr
Sub-Investigator: Denis VINATIER, MD
Sub-Investigator: Loic BOULANGER, MD
Sub-Investigator: Chrystèle RUBOD, MD
Principal Investigator: PIerre COLLINET, MD, PhD
CHU Limoges	Recruiting
Limoges, France, 87042
Contact: Tristan GAUTHIER, MD +33(0)555056164 tristan.gauthier@chu-limoges.fr
Sub-Investigator: Yves AUBARD, MD
Sub-Investigator: Ousmane LOUM, MD
Principal Investigator: Tristan GAUTHIER, MD
Institut Paoli Calmette	Recruiting
Marseille, France, 13009
Contact: Gilles HOUVENAEGHEL, MD +33(0)491223333 houvenag@marseille.fnclcc.fr
Sub-Investigator: Eric LAMBAUDIE, MD
Sub-Investigator: Marie BANNIER, MD
Sub-Investigator: Max BUTARELLI, MD
Sub-Investigator: Jérémie DE TROYER, MD
Sub-Investigator: Virginia MICHEL, MD
Principal Investigator: Gilles HOUVENAEGHEL, MD, PhD
Sub-Investigator: Daniel FRANCON, MD
CHU Nîmes	Recruiting
Nimes, France, 30029
Contact: Catherine FERRER, MD +33(0)466683216 catherine.ferrer@chu-nimes.fr
Sub-Investigator: Florent MASIA, MD
Polyclinique KenVal	Recruiting
Nimes, France, 30900
Contact: Gregory TRIOPON, MD 33 4 66 67 66 66 gtriopon@hotmail.com
Principal Investigator: Grégory TRIOPON, MD
Sub-Investigator: Olivier ROUSSEAU, MD
Hôpital Européen Georges Pompidou	Recruiting
Paris, France, 75015
Contact: Fabrice LECURU, MD +33(0)156093584 fabrice.lecuru@egp.aphp.fr
Sub-Investigator: Anne-Sophie BATS, MD
Sub-Investigator: Chahrazed BENSAID, MD
Polyclinique Courlancy	Recruiting
Reims, France, 51100
Contact: Stéphane URRUTIAGUER, MD 33 3.26.77.27.55 stephane.urrutiagger@free.fr
Principal Investigator: Stéphane URRUTIAGUER, MD
Sub-Investigator: Abdol Reza MAJIDI-AHI, MD
Centre hospitalier de Roubaix	Recruiting
Roubaix, France, 59056
Contact: Ndaye MUBIAYI, MD 03 20 99 32 16 ndaye.mubiayi@ch-roubaix.fr
Principal Investigator: Ndaye MUBIAYI, MD
Institut de Cancérologie de l'Ouest Site René Gauducheau	Recruiting
St HERBLAIN, France, 44805
Contact: J-Marc CLASSE, MD 33 2.40.67.99.59 jean-marc.classe@ico.unicancer.fr
Principal Investigator: J-Marc CLASSE, MD
CHU Rangueil	Recruiting
Toulouse, France, 31059
Contact: Pierre LEGUEVAQUE, MD +33(0)561323752 leguevaque.p@chu-toulouse.fr
Sub-Investigator: Stéphanie MOTTON, MD
Principal Investigator: PIerre LEGUEVAQUE, MD
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Denis QUERLEU, MD +33(0)561424157 querleu.denis@claudiusregaud.fr
Sub-Investigator: Gwenael FERRON, MD
Sub-Investigator: Yves FOUCHE, MD
Sub-Investigator: Eva JOUVE, MD
Principal Investigator: Denis QUERLEU, MD, PhD
CHRU de Tours	Recruiting
Tours, France, 37044
Contact: Thomas HEBERT, MD 02 47 47 47 47 t.hebert@chu-tours.fr
Principal Investigator: Thomas HEBERT, MD
Sub-Investigator: Olivier ACKER, MD
Sub-Investigator: Henri MARRET, MD, PhD
Sub-Investigator: Lobna OULDAMER, MD
Centre Hospitalier de Valenciennes	Recruiting
Valenciennes, France, 59322
Contact: Jérôme PHALIPPOU, MD 03 27 14 01 30 phalippou-j@ch-valenciennes.fr
Principal Investigator: Jerome PHALIPPOU, MD
Sub-Investigator: Antoine DRAIN, MD
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: François GUILLEMIN, MD +33(0)383598451 f.guillemin@nancy.fnclcc.fr
Sub-Investigator: Frédéric MARCHAL, MD
Principal Investigator: François GUILLEMIN, MD

Sponsors and Collaborators

Centre Oscar Lambret

CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie

Investigators


Principal Investigator:	Fabrice NARDUCCI, MD	Centre Oscar Lambret, Lille
Study Director:	Yvette VENDEL, Sponsor CRA	Centre Oscar Lambret

More Information

No publications provided


Responsible Party:	Centre Oscar Lambret
ClinicalTrials.gov Identifier:	NCT01247779 History of Changes
Other Study ID Numbers:	ROBOGYN - 1004, 2010-A00605-34
Study First Received:	November 19, 2010
Last Updated:	June 20, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:


gynecology oncology coelioscopy robot morbidity

ClinicalTrials.gov processed this record on February 27, 2015

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