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

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Ovarian Cancer

Treatments: Device: Caiman® device

Study type: Interventional

Funder types: Other

Identifiers

NCT03219242

25543/16

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Caiman device

Experimental group

Description:

Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device

Treatment:

Device: Caiman® device