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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01247779
Other study ID # ROBOGYN - 1004
Secondary ID 2010-A00605-34
Status Completed
Phase N/A
First received
Last updated
Start date December 2010
Est. completion date November 2017

Study information

Verified date March 2019
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
gynecologic surgery - standard coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
gynecologic surgery - robot assisted coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Centre Oscar Lambret CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

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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