NCT02324595

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Phase II multicentric study

Detailed description

The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.

Conditions

• Stage IV Ovarian Carcinoma
• Effects of Chemotherapy
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2016-02-01
• First posted: 2014-12-24
• Last updated: 2016-04-13

Locations

2 sites across 1 country: Italy