An observational study in Residual Tumor, Disease-free Survival and Overall Survival, sponsored by Università degli Studi dell'Insubria. Completed at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2016-12-02.
Sponsored by Università degli Studi dell'Insubria · Observational
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.
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.
272 studies on the registry are indexed under Neoplasm, Residual; 124 are open to participants now.
This study's enrollment of 66 is below the median of 100 across 89 observational studies indexed under Neoplasm, Residual.
Browse Neoplasm, Residual studies →Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
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Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred Heart Hospital, Negrar, Italy
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Exclusion Criteria:
Patients in whom primary cytoreduction was performed using a laparoscopic approach
Procedure: Laparoscopic primary cytoreduction
Patients in whom primary cytoreduction was performed using an open abdominal approach
Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach
Residual tumor at the end of surgery (using the completeness of cytoreduction score)
Time frame: June 2007 - July 2015
Disease-free Survival
Time frame: June 2007 - July 2016
Overall Survival
Time frame: June 2007 - July 2016
Plan to share: No
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria