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Clinical Trials/NCT03219242
NCT03219242UnknownNot Applicable

Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology

Catholic University of the Sacred Heart2 sites in 1 country40 target enrollmentStarted: June 30, 2016Last updated:
Conditions
Interventions

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

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Giovanni Scambia

Director

Catholic University of the Sacred Heart

Study Sites (2)

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