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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02980185
Enrollment
66
Registered
2016-12-02
Start date
2007-06-30
Completion date
2016-10-31
Last updated
2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease-free Survival, Overall Survival, Residual Tumor

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.

Interventions

PROCEDURELaparoscopic primary cytoreduction

Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Residual tumor at the end of surgery (using the completeness of cytoreduction score)June 2007 - July 2015

Secondary

MeasureTime frame
Disease-free SurvivalJune 2007 - July 2016
Overall SurvivalJune 2007 - July 2016

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026