Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- time-sparing for bowel resection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Caiman device
Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
Intervention: Caiman® device (Device)
Outcomes
Primary Outcomes
time-sparing for bowel resection
Time Frame: up to 1 hour
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Post surgical complications
Time Frame: Up to 6 months
F-up in 1-3 and 6 months with questionnaire
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Giovanni Scambia
Director
Catholic University of the Sacred Heart