Title :

Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: results of the randomized robogyn-1004 trial

Author(s) :

Narducci, Fabrice [Auteur]
Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192
Bogart, Emilie [Auteur]
Hebert, Thomas [Auteur]
Gauthier, Tristan [Auteur]
Collinet, Pierre [Auteur]
Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189
Classe, Jean-Marc [Auteur]
Lecuru, Fabrice [Auteur]
Delest, Alain [Auteur]
Motton, Stephanie [Auteur]
Conri, Vanessa [Auteur]
Ferrer, Catherine [Auteur]
Marchal, Frederic [Auteur]
Ferron, Gwenael [Auteur]
Probst, Alicia [Auteur]
Thery, Julien [Auteur]
Le Deley, Marie-Cecile [Auteur]
Lefebvre, Daniele [Auteur]
Francon, Daniel [Auteur]
Leblanc, Eric [Auteur]
Lambaudie, Eric [Auteur]

Journal title :

Gynecologic oncology

Abbreviated title :

Gynecol. Oncol.

Publication date :

2020-05-25

ISSN :

1095-6859

Keyword(s) :

Conventional laparoscopy
Morbidity
Randomized phase III trial
Robot-assisted laparoscopy
Gynecologic oncology

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved ...
Show more >OBJECTIVE: In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence. METHODS: ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery). RESULTS: Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups. CONCLUSIONS: RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

INSERM
Université de Lille

Collections :

• Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192

Submission date :

2022-06-15T13:59:44Z