Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
Overview
Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology
Full Title of Study: “Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: July 1, 2016
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
- Device: Caiman® device
- Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.
Arms, Groups and Cohorts
- Experimental: Caiman device
- Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Catholic University of the Sacred Heart
- Provider of Information About this Clinical Study
- Principal Investigator: Prof. Giovanni Scambia, Director – Catholic University of the Sacred Heart
- Overall Official(s)
- Giovanni Scambia, Professor, Principal Investigator, Catholic University of Sacred Heart
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