Overview

This trial is active, not recruiting.

Conditions cervical cancer, uterus cancer, ovarian cancer
Treatments gynecologic surgery - standard coelioscopy, gynecologic surgery - robot assisted coelioscopy
Phase phase 3
Sponsor Centre Oscar Lambret
Collaborator CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
Start date December 2010
End date June 2017
Trial size 386 participants
Trial identifier NCT01247779, 2010-A00605-34, ROBOGYN - 1004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
gynecologic surgery - standard coelioscopy
gynecologic surgery - standard coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
(Experimental)
gynecologic surgery - robot assisted coelioscopy
gynecologic surgery - robot assisted coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Primary Outcomes

Measure
Perioperative morbidity at six months
time frame: six months after surgery

Secondary Outcomes

Measure
Anesthesic and ventilator parameters
time frame: every 30 min during the surgery
Post-operative analgesia
time frame: at 24h, 48h after sugery and until discharge
Surgeon's ergonomy
time frame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)
Quality of Life
time frame: until 2 years after surgery
Description of surgical procedures
time frame: during surgery
Progression-free survival
time frame: until 2 years after surgery
Anatomopathology
time frame: during surgery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
Principal investigator Fabrice NARDUCCI, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.