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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980185
Other study ID # 541
Secondary ID
Status Completed
Phase N/A
First received November 26, 2016
Last updated November 29, 2016
Start date June 2007
Est. completion date October 2016

Study information

Verified date November 2016
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date October 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Primary Ovarian cancer

- Epithelial histotype

- Stage III-IV disease

Exclusion Criteria:

- Anesthesiological contraindication to primary cytoreduction

- Extension of disease contraindicating primary cytoreduction

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Laparoscopic primary cytoreduction
Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach

Locations

Country Name City State
Italy Department of Obstetrics and Gynecology Universita' Dell'Insubria Varese

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Residual tumor at the end of surgery (using the completeness of cytoreduction score) June 2007 - July 2015 No
Secondary Disease-free Survival June 2007 - July 2016 No
Secondary Overall Survival June 2007 - July 2016 No
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