Trial record 13 of 332 for:
Open Studies | "Uterine Neoplasms"
Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy (ROBO-GYN)
This study is currently recruiting participants.
Verified July 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
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: July 20, 2012
Last verified: July 2012
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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 2015 |
| Estimated Primary Completion Date: | June 2015 (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
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 | |
| 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 | |
| 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 | |
| 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 |
| Study First Received: | November 19, 2010 |
| Last Updated: | July 20, 2012 |
| 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 Uterine Cervical Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 23, 2013