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Validation of a Laparoscopic Score to Predict the Chance of Optimal Cytoreduction in Advanced Ovarian Cancer Patients

NCT01595204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2012-05-22

No results posted yet for this study

Summary

Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic score to predict possibility of optimal cytoreduction in patients with ovarian / tubal / peritoneal advanced at the time of first surgery. The study consists of subjecting all patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs).

Laparoscopy should be described and recorded in electronic form. After the procedure each patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI). The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The data collected and the video should be sent to the Center Coordinator, who will determine the adequacy of the procedure and the accuracy of the score enrollment is completed for each center. All eligible subjects will be considered by intention-to-treat population (ITT). For this phase of the study, it is not necessary know the outcome of the surgical patient (RT) or if it was then subjected to exploratory laparotomy or less.

Conditions

  • Cancer of Ovary

Interventions

PROCEDURE

Diagnostic laparoscopy

Laparoscopy will be performed in each case of clinical/radiological suspicious primary advanced ovarian/peritoneal cancer. After the introduction of the trocar and the optic, pneumoperitoneum is induced and one or two ancillary trocars are inserted in the iliac fossae bilaterally or where it is possible. A careful complete abdominal and pelvic inspection is carried out in order to identify any possible cause of non optimal cytoreduction. All peritoneal surfaces and the gutters are closely examined and the liver is evaluated by rotating the laparoscope 360° through the umbilical port using grasping forceps as retractors. The small bowel loops and mesentery are evaluated by carefully folding back the various intestinal segments. The pelvis is explored after the bowel loops are retracted in the upper abdomen when possible. At the end of laparoscopy, a PI value is elaborated, based on table given to participant centers.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Anna Fagotti, MD PhD · Catholic University of Sacred Heart

  • Giovanni Scambia, MD · Catholic University of Sacred Heart

  • Francesco Fanfani, MD · Catholic University of Sacred Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595204 on ClinicalTrials.gov