Clinical trial NCT02980185: Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer
Official title: Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residual Tumor
Disease-free Survival
Overall Survival
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary cytoreduction for stage III-IV ovarian cancer at the Sacred Heart Hospital, Negrar, Italy

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.

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

Primary outcomes:
measure: Residual tumor at the end of surgery (using the completeness of cytoreduction score)
timeFrame: June 2007 - July 2015
Secondary outcomes:
measure: Disease-free Survival
timeFrame: June 2007 - July 2016
measure: Overall Survival
timeFrame: June 2007 - July 2016
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Obstetrics and Gynecology Universita' Dell'Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Stefano Uccella, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.