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OpenTrials
Completed

NCT Number: NCT02980185

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Laparoscopic primary cytoreduction

Procedure

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

Primary outcomes

  1. Residual tumor at the end of surgery (using the completeness of cytoreduction score)

    Time frame: June 2007 - July 2015

Secondary outcomes

  1. Disease-free Survival

    Time frame: June 2007 - July 2016

  2. Overall Survival

    Time frame: June 2007 - July 2016

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2016
First posted
Dec 2, 2016
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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