Clinical trial NCT01247779: Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
Official title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Uterus Cancer
Ovarian Cancer
Keywords: gynecology
oncology
coelioscopy
robot
morbidity
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
name: National Cancer Institute, France
First posted: 2010-11-24
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

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 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

Primary outcomes:
measure: Perioperative morbidity at six months
timeFrame: six months after surgery
Secondary outcomes:
measure: Anesthesic and ventilator parameters
timeFrame: every 30 min during the surgery
measure: Post-operative analgesia
timeFrame: at 24h, 48h after sugery and until discharge
measure: Surgeon's ergonomy
timeFrame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)
measure: Patient-reported survey of patient health
timeFrame: until 2 years after surgery
measure: Description of surgical procedures
timeFrame: during surgery
measure: Progression-free survival
timeFrame: until 2 years after surgery
measure: Anatomopathology
timeFrame: during surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux, Hôpital Saint-André
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille, Hôpital Jeanne de Flandres
city: Limoges
country: France
facility: CHU Limoges
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nimes
country: France
facility: CHU Nîmes
city: Nimes
country: France
facility: Polyclinique KenVal
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Reims
country: France
facility: Polyclinique Courlancy
city: Roubaix
country: France
facility: Centre hospitalier de Roubaix
city: St HERBLAIN
country: France
facility: Institut de Cancérologie de l'Ouest Site René Gauducheau
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: CHRU de Tours
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Oscar Lambret, Lille
name: Fabrice NARDUCCI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Paoli-Calmettes
name: Eric LAMBAUDIE, MD
role: STUDY_DIRECTOR
References:
citation: 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.