Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy (ROBO-GYN)
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ClinicalTrials.gov Identifier: NCT01247779 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 24, 2010
Last Update Posted
: July 21, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer Uterus Cancer Ovarian Cancer | Procedure: gynecologic surgery - standard coelioscopy Procedure: gynecologic surgery - robot assisted coelioscopy | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 386 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy |
Actual Study Start Date : | December 2010 |
Actual Primary Completion Date : | May 2016 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
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
|
- Perioperative morbidity at six months [ Time Frame: six months after surgery ]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
- Anesthesic and ventilator parameters [ Time Frame: every 30 min during the surgery ]Description of anesthesic and ventilator parameters
- Post-operative analgesia [ Time Frame: at 24h, 48h after sugery and until discharge ]collect of antalgic treatments
- Surgeon's ergonomy [ Time Frame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale) ]according to Borg and NASA-TLX scales
- Quality of Life [ Time Frame: until 2 years after surgery ]according to SF-36 questionnaire
- Description of surgical procedures [ Time Frame: during surgery ]operative time (overall intervention, incision or "skin-to-skin", robot).
- Progression-free survival [ Time Frame: until 2 years after surgery ]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 ]rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247779
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 |
Principal Investigator: | Fabrice NARDUCCI, MD | Centre Oscar Lambret, Lille | |
Study Director: | Eric LAMBAUDIE, MD | Institut Paoli-Calmettes |
Responsible Party: | Centre Oscar Lambret |
ClinicalTrials.gov Identifier: | NCT01247779 History of Changes |
Other Study ID Numbers: |
ROBOGYN - 1004 2010-A00605-34 ( Other Identifier: IDRCB Number (ANSM_DEDIM) ) |
First Posted: | November 24, 2010 Key Record Dates |
Last Update Posted: | July 21, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Centre Oscar Lambret:
gynecology oncology coelioscopy robot morbidity |
Additional relevant MeSH terms:
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |