NCT02980185

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.

Detailed description

All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

Conditions

• Residual Tumor
• Disease-free Survival
• Overall Survival

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic primary cytoreduction	Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach

Timeline

• Start date: 2007-06-01
• Primary completion: 2015-07-01
• Completion: 2016-10-01
• First posted: 2016-12-02
• Last updated: 2016-12-02

Locations

1 site across 1 country: Italy