Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

NCT02980185 | Completed

• 1 other identifier: 541
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Residual Tumor; Disease-free Survival; Overall Survival

Outcome Measures

Primary Outcomes (1)

• Residual tumor at the end of surgery (using the completeness of cytoreduction score)

  June 2007 - July 2015

Secondary Outcomes (2)

• Disease-free Survival

  June 2007 - July 2016

• Overall Survival

  June 2007 - July 2016

Study Arms (2)

Laparoscopic primary cytoreduction

Patients in whom primary cytoreduction was performed using a laparoscopic approach

Procedure: Laparoscopic primary cytoreduction

Abdominal primary cytoreduction

Patients in whom primary cytoreduction was performed using an open abdominal approach

Interventions

Laparoscopic primary cytoreduction PROCEDURE

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

Laparoscopic primary cytoreduction

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

Location

Related Publications (2)

• 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.

  PMID: 20932362 BACKGROUND

• 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.

  PMID: 29052073 DERIVED

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Uccella, MD, PhD

  Università degli Studi dell'Insubria

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: December 2, 2016
• Study Start: June 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)