Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

February 29, 2016

Conditions
Stage IV Ovarian CarcinomaEffects of ChemotherapyPeritoneal Cavity Cancer
Interventions
PROCEDURE

Laparoscopic interval debulking surgery

"Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm flexible tip videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered"

Trial Locations (2)

00100

Catholic University of Sacred Heart Rome,, Rome

00168

Policlinico Agostino Gemelli, Rome

All Listed Sponsors
collaborator

Fagotti, Anna, M.D.

INDIV

collaborator

Fanfani, Francesco, M.D.

INDIV

collaborator

Salvatore Gueli Alletti

UNKNOWN

lead

Catholic University of the Sacred Heart

OTHER

NCT02324595 - Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study | Biotech Hunter | Biotech Hunter