Ovarian Cancer Clinical Trial
— ROBO-GYNOfficial title:
Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
Verified date | March 2019 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.
Status | Completed |
Enrollment | 386 |
Est. completion date | November 2017 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Bordeaux, Hôpital Saint-André | Bordeaux | |
France | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | |
France | Centre Oscar Lambret | Lille | |
France | CHRU Lille, Hôpital Jeanne de Flandres | Lille | |
France | CHU Limoges | Limoges | |
France | Institut Paoli Calmette | Marseille | |
France | CHU Nîmes | Nimes | |
France | Polyclinique KenVal | Nimes | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | Polyclinique Courlancy | Reims | |
France | Centre hospitalier de Roubaix | Roubaix | |
France | Institut de Cancérologie de l'Ouest Site René Gauducheau | St HERBLAIN | |
France | CHU Rangueil | Toulouse | |
France | Institut Claudius Regaud | Toulouse | |
France | CHRU de Tours | Tours | |
France | Centre Hospitalier de Valenciennes | Valenciennes | |
France | Centre Alexis Vautrin | Vandoeuvre-les-Nancy |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie, National Cancer Institute, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Anesthesic and ventilator parameters | Description of anesthesic and ventilator parameters | every 30 min during the surgery | |
Secondary | Post-operative analgesia | collect of antalgic treatments | at 24h, 48h after sugery and until discharge | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | Description of surgical procedures | operative time (overall intervention, incision or "skin-to-skin", robot). | during surgery | |
Secondary | 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 | |
Secondary | Anatomopathology | rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed. | during surgery |
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