Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology

N/AUnknownNCT03219242

Catholic University of the Sacred Heart40 enrolled

Overview

Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Caiman® deviceDEVICE

Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Catholic University of Sacred Heart Rome,

Rome, Rome, Italy

Outcomes

Primary Outcomes

time-sparing for bowel resection

Time needed for bowel resection and radical omentecomy in avanced ovarian cancer

Time frame: up to 1 hour

Post surgical complications

F-up in 1-3 and 6 months with questionnaire

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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