Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Residual Tumor; Overall Survival; Disease-free Survival
• Intervention / Treatment: Procedure: Laparoscopic primary cytoreduction

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Department of Obstetrics and Gynecology Universita' Dell'Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred Heart Hospital, Negrar, Italy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic primary cytoreduction; Patients in whom primary cytoreduction was performed using a laparoscopic approach	Procedure: Laparoscopic primary cytoreduction; Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach
Abdominal primary cytoreduction; Patients in whom primary cytoreduction was performed using an open abdominal approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Study Chair: Stefano Uccella, MD, PhD, Università degli Studi dell'Insubria

Publications and helpful links

General Publications

• 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.
• Ceccaroni M, Roviglione G, Bruni F, Clarizia R, Ruffo G, Salgarello M, Peiretti M, Uccella S. Laparoscopy for primary cytoreduction with multivisceral resections in advanced ovarian cancer: prospective validation. "The times they are a-changin"? Surg Endosc. 2018 Apr;32(4):2026-2037. doi: 10.1007/s00464-017-5899-9. Epub 2017 Oct 19.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 26, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): December 2, 2016

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm, Residual
• Other Study ID Numbers: 541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO