Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy (ROBO-GYN)

Centre Oscar Lambret

Status: Completed

Conditions: Uterus Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Procedure: gynecologic surgery - robot assisted coelioscopy; Procedure: gynecologic surgery - standard coelioscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01247779

ROBOGYN - 1004

2010-A00605-34 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 386 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

Standard Coelioscopy

Active Comparator group

Description:

gynecologic surgery - standard coelioscopy

Treatment:

Procedure: gynecologic surgery - standard coelioscopy

Robot-assisted coelioscopy

Experimental group

Description:

gynecologic surgery - robot assisted coelioscopy

Treatment:

Procedure: gynecologic surgery - robot assisted coelioscopy