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Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

U

Università degli Studi dell'Insubria

Status

Completed

Conditions

Disease-free Survival
Residual Tumor
Overall Survival

Treatments

Procedure: Laparoscopic primary cytoreduction

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

66 participants in 2 patient groups

Laparoscopic primary cytoreduction
Description:
Patients in whom primary cytoreduction was performed using a laparoscopic approach
Treatment:
Procedure: Laparoscopic primary cytoreduction
Abdominal primary cytoreduction
Description:
Patients in whom primary cytoreduction was performed using an open abdominal approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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