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 January 2016 by Centre Oscar Lambret
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: November 19, 2010
Last updated: January 5, 2016
Last verified: January 2016
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: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : 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 hour 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: 386
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (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


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

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 breastfeeding woman
  • patient unable to proceed follow-up visit, because of geographic, social or mental 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 identifier: NCT01247779

Contact: Fabrice NARDUCCI, MD +33(0)320295918

CHU Bordeaux, Hôpital Saint-André Recruiting
Bordeaux, France, 33300
Contact: Vanessa CONRI, MD    +33(0)556795835   
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   
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   
Contact: Yvette VENDEL, CRA    +33(0)320295940   
Sub-Investigator: Eric LEBLANC, MD         
Principal Investigator: Fabrice NARDUCCI, MD         
Sub-Investigator: Lucie BRESSON, MD         
Sub-Investigator: Danièle LEFEBVRE-KUNTZ, MD         
CHRU Lille, Hôpital Jeanne de Flandres Recruiting
Lille, France, 59037
Contact: Pierre COLLINET, MD    +33(0)320446388   
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   
Sub-Investigator: Yves AUBARD, MD         
Sub-Investigator: Anne VINCELOT, MD         
Principal Investigator: Tristan GAUTHIER, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13009
Contact: Gilles HOUVENAEGHEL, MD    +33(0)491223333   
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         
Sub-Investigator: Elisabeth CHEREAU, MD         
CHU Nîmes Recruiting
Nimes, France, 30029
Contact: Catherine FERRER, MD    +33(0)466683216   
Sub-Investigator: Florent MASIA, MD         
Polyclinique KenVal Suspended
Nimes, France, 30900
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Fabrice LECURU, MD    +33(0)156093584   
Sub-Investigator: Anne-Sophie BATS, MD         
Sub-Investigator: Chahrazed BENSAID, MD         
Polyclinique Courlancy Suspended
Reims, France, 51100
Centre hospitalier de Roubaix Suspended
Roubaix, France, 59056
Institut de Cancérologie de l'Ouest Site René Gauducheau Recruiting
St HERBLAIN, France, 44805
Contact: J-Marc CLASSE, MD    33   
Principal Investigator: J-Marc CLASSE, MD         
Sub-Investigator: Isabelle JAFFRE, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Denis QUERLEU, MD    +33(0)561424157   
Sub-Investigator: Gwenael FERRON, MD         
Sub-Investigator: Yves FOUCHE, MD         
Sub-Investigator: Eva JOUVE, MD         
Principal Investigator: Denis QUERLEU, MD, PhD         
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Pierre LEGUEVAQUE, MD    +33(0)561323752   
Sub-Investigator: Stéphanie MOTTON, MD         
Principal Investigator: PIerre LEGUEVAQUE, MD         
CHRU de Tours Recruiting
Tours, France, 37044
Contact: Thomas HEBERT, MD    02 47 47 47 47   
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 Suspended
Valenciennes, France, 59322
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: François GUILLEMIN, MD    +33(0)383598451   
Sub-Investigator: Frédéric MARCHAL, MD         
Principal Investigator: François GUILLEMIN, MD         
Sponsors and Collaborators
Centre Oscar Lambret
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
Principal Investigator: Fabrice NARDUCCI, MD Centre Oscar Lambret, Lille
Study Director: Eric LAMBAUDIE, MD Institut Paoli-Calmettes
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret Identifier: NCT01247779     History of Changes
Other Study ID Numbers: ROBOGYN - 1004  2010-A00605-34 
Study First Received: November 19, 2010
Last Updated: January 5, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Oscar Lambret:

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms processed this record on February 07, 2016