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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Oscar Lambret
Sponsor:
Collaborator:
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01247779
First received: November 19, 2010
Last updated: June 20, 2014
Last verified: June 2014
  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:


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
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         
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         
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         
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         
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

Additional relevant MeSH terms:
Uterine Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on October 21, 2014