Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

Completed

• Conditions: Residual Tumor; Disease-free Survival; Overall Survival
• Interventions: Procedure: Laparoscopic primary cytoreduction

• Registration Number: NCT02980185
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2015-07
• Study Completion: 2016-10
• Status Verified: 2016-11
• Study First Submitted: 2016-11-26
• Study First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Primary Ovarian cancer
• Epithelial histotype
• Stage III-IV disease

Exclusion Criteria

• Anesthesiological contraindication to primary cytoreduction
• Extension of disease contraindicating primary cytoreduction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic primary cytoreduction	Laparoscopic primary cytoreduction	Patients in whom primary cytoreduction was performed using a laparoscopic approach

Primary Outcome Measures

Name	Time	Method
Residual tumor at the end of surgery (using the completeness of cytoreduction score)	June 2007 - July 2015

Secondary Outcome Measures

Name	Time	Method
Overall Survival	June 2007 - July 2016
Disease-free Survival	June 2007 - July 2016

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria; 🇮🇹 Varese, Italy