Ovarian Cancer
Conditions
Keywords
Advanced ovarian cancer
Brief summary
Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology
Detailed description
Using CAIMAN® technology in primary surgery for advanced ovarian cancer including bowel resections. Analyze potential time-sparing and the incidence of post-surgical complications. Prospective, longitudinal, observational. 40 patients / year.
Interventions
DEVICECaiman® device
Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≤ 75 years * Patients with advanced ovarian cancer (FIGO stage IIIC-IV). * Bowel resection * Class 0-2 according to the American Society of Anesthesiologists (i.e.: ASA score ≤ 2) * Written informed consent to the study
Exclusion criteria
* Pregnant or chronic infections * Previous pelvic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time-sparing for bowel resection | up to 1 hour | Time needed for bowel resection and radical omentecomy in avanced ovarian cancer |
| Post surgical complications | Up to 6 months | F-up in 1-3 and 6 months with questionnaire |
Countries
Italy
Outcome results
None listed