Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Residual Tumor, Disease-free Survival, Overall Survival

Intervention / Treatment
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* Procedure: Laparoscopic primary cytoreduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Ovarian cancer Epithelial histotype Stage III-IV disease Exclusion Criteria: Anesthesiological contraindication to primary cytoreduction Extension of disease contraindicating primary cytoreduction
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic primary cytoreduction<br>Patients in whom primary cytoreduction was performed using a laparoscopic approach | Procedure: Laparoscopic primary cytoreduction<br>* Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach<br>|
| Abdominal primary cytoreduction<br>Patients in whom primary cytoreduction was performed using an open abdominal approach | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual tumor at the end of surgery (using the completeness of cytoreduction score) |  | June 2007 - July 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival |  | June 2007 - July 2016 | 
| Overall Survival |  | June 2007 - July 2016 |