Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
ROBO-GYN
Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
3 other identifiers
interventional
386
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 13, 2026
March 1, 2026
5.3 years
November 19, 2010
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Anesthesic and ventilator parameters
every 30 min during the surgery
Post-operative analgesia
at 24h, 48h after sugery and until discharge
Surgeon's ergonomy
every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)
Patient-reported survey of patient health
until 2 years after surgery
Description of surgical procedures
during surgery
- +2 more secondary outcomes
Study Arms (2)
Standard Coelioscopy
ACTIVE COMPARATORgynecologic surgery - standard coelioscopy
Robot-assisted coelioscopy
EXPERIMENTALgynecologic surgery - robot assisted coelioscopy
Interventions
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- metastatic disease
- pregnant or breastfeeding woman
- patient unable to proceed follow-up visit, because of geographic, social or mental reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CHU Bordeaux, Hôpital Saint-André
Bordeaux, 33300, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Centre Oscar Lambret
Lille, 59000, France
CHRU Lille, Hôpital Jeanne de Flandres
Lille, 59037, France
CHU Limoges
Limoges, 87042, France
Institut Paoli Calmette
Marseille, 13009, France
CHU Nîmes
Nîmes, 30029, France
Polyclinique KenVal
Nîmes, 30900, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Polyclinique Courlancy
Reims, 51100, France
Centre hospitalier de Roubaix
Roubaix, 59056, France
Institut de Cancérologie de l'Ouest Site René Gauducheau
Saint-Herblain, 44805, France
Institut Claudius Regaud
Toulouse, 31052, France
CHU Rangueil
Toulouse, 31059, France
CHRU de Tours
Tours, 37044, France
Centre Hospitalier de Valenciennes
Valenciennes, 59322, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
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.
PMID: 32467054DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice NARDUCCI, MD
Centre Oscar Lambret, Lille
- STUDY DIRECTOR
Eric LAMBAUDIE, MD
Institut Paoli-Calmettes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 24, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2016
Study Completion
November 1, 2017
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share