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

This study is ongoing, but not recruiting participants.
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: February 15, 2016
Last verified: February 2016
  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: 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.


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
gynecologic surgery - standard coelioscopy
Procedure: gynecologic surgery - standard coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
Experimental: Robot-assisted coelioscopy
gynecologic surgery - robot assisted coelioscopy
Procedure: gynecologic surgery - robot assisted coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

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 gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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 ClinicalTrials.gov identifier: NCT01247779

Locations
France
CHU Bordeaux, Hôpital Saint-André
Bordeaux, France, 33300
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Centre Oscar Lambret
Lille, France, 59000
CHRU Lille, Hôpital Jeanne de Flandres
Lille, France, 59037
CHU Limoges
Limoges, France, 87042
Institut Paoli Calmette
Marseille, France, 13009
CHU Nîmes
Nimes, France, 30029
Polyclinique KenVal
Nimes, France, 30900
Hôpital Européen Georges Pompidou
Paris, France, 75015
Polyclinique Courlancy
Reims, France, 51100
Centre hospitalier de Roubaix
Roubaix, France, 59056
Institut de Cancérologie de l'Ouest Site René Gauducheau
St HERBLAIN, France, 44805
Institut Claudius Regaud
Toulouse, France, 31052
CHU Rangueil
Toulouse, France, 31059
CHRU de Tours
Tours, France, 37044
Centre Hospitalier de Valenciennes
Valenciennes, France, 59322
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
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: Eric LAMBAUDIE, MD Institut Paoli-Calmettes
  More Information

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: February 15, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
gynecology
oncology
coelioscopy
robot
morbidity

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 25, 2016