Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

NCT ID: NCT02980185

Last Updated: 2016-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2016-10-31

Brief 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.

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.

Conditions

Residual Tumor; Disease-free Survival; Overall Survival

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparoscopic primary cytoreduction

Patients in whom primary cytoreduction was performed using a laparoscopic approach

Laparoscopic primary cytoreduction

Intervention Type: PROCEDURE

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

No interventions assigned to this group

Interventions

Laparoscopic primary cytoreduction

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Stefano Uccella

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Uccella, MD, PhD

Role: STUDY_CHAIR

Università degli Studi dell'Insubria

Locations

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 20932362 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29052073 (View on PubMed)

Other Identifiers

541

Identifier Type: -

Identifier Source: org_study_id