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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC10-1908 | Other Grant/Funding Number | DGOS/INCA | |
| 2010-A00605-34 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie | UNKNOWN |
| National Cancer Institute, France | OTHER_GOV |
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The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Coelioscopy | Active Comparator | gynecologic surgery - standard coelioscopy |
|
| Robot-assisted coelioscopy | Experimental | gynecologic surgery - robot assisted coelioscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gynecologic surgery - standard coelioscopy | Procedure | lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative morbidity at six months | 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 | six months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesic and ventilator parameters | Description of anesthesic and ventilator parameters | every 30 min during the surgery |
| Post-operative analgesia | collect of antalgic treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice NARDUCCI, MD | Centre Oscar Lambret, Lille | Principal Investigator |
| Eric LAMBAUDIE, MD | Institut Paoli-Calmettes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux, Hôpital Saint-André | Bordeaux | 33300 | France | |||
| Polyclinique Bordeaux Nord Aquitaine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32467054 | Derived | Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25. |
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| gynecologic surgery - robot assisted coelioscopy | Procedure | lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy |
|
| at 24h, 48h after sugery and until discharge |
| Surgeon's ergonomy | according to Borg and NASA-TLX scales | every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale) |
| Patient-reported survey of patient health | 36-item short form health Survey (SF36) : Scoring is a two-step process. First, numeric values of all items are recoded per the scoring key (for example, values are 0/100, or 0/25/50/75/100 depending the items). All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores: physical functioning, Role functioning/physical, Role functioning/emotional, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change. Scale scores represent the average for all items in the scale that the respondent answered. | until 2 years after surgery |
| Description of surgical procedures | operative time (overall intervention, incision or "skin-to-skin", robot). | during surgery |
| Progression-free survival | delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death. | until 2 years after surgery |
| Anatomopathology | rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed. | during surgery |
| Bordeaux |
| 33300 |
| France |
| Centre Oscar Lambret | Lille | 59000 | France |
| CHRU Lille, Hôpital Jeanne de Flandres | Lille | 59037 | France |
| CHU Limoges | Limoges | 87042 | France |
| Institut Paoli Calmette | Marseille | 13009 | France |
| CHU Nîmes | Nîmes | 30029 | France |
| Polyclinique KenVal | Nîmes | 30900 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Polyclinique Courlancy | Reims | 51100 | France |
| Centre hospitalier de Roubaix | Roubaix | 59056 | France |
| Institut de Cancérologie de l'Ouest Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| CHRU de Tours | Tours | 37044 | France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59322 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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