Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

NCT ID: NCT01247779

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-11-30

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.

Conditions

Cervical Cancer; Uterus Cancer; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Coelioscopy

gynecologic surgery - standard coelioscopy

Group Type: ACTIVE_COMPARATOR

gynecologic surgery - standard coelioscopy

Intervention Type: PROCEDURE

lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Robot-assisted coelioscopy

gynecologic surgery - robot assisted coelioscopy

Group Type: EXPERIMENTAL

gynecologic surgery - robot assisted coelioscopy

Intervention Type: PROCEDURE

lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Interventions

gynecologic surgery - standard coelioscopy

lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Intervention Type: PROCEDURE

gynecologic surgery - robot assisted coelioscopy

lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice NARDUCCI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret, Lille

Eric LAMBAUDIE, MD

Role: STUDY_DIRECTOR

Institut Paoli-Calmettes

Locations

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

Nîmes, , France

Polyclinique KenVal

Nîmes, , 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

Saint-Herblain, , France

Institut Claudius Regaud

Toulouse, , France

CHU Rangueil

Toulouse, , France

CHRU de Tours

Tours, , France

Centre Hospitalier de Valenciennes

Valenciennes, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32467054 (View on PubMed)

Other Identifiers

2010-A00605-34

Identifier Type: OTHER

Identifier Source: secondary_id

ROBOGYN - 1004

Identifier Type: -

Identifier Source: org_study_id