Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
Not Applicable
- Conditions
- Ovarian Cancer
- Interventions
- Device: Caiman® device
- Registration Number
- NCT03219242
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Caiman device Caiman® device Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Catholic University of Sacred Heart Rome,
🇮🇹Rome,, Rome, Italy