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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