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

Ovarian Cancer Clinical Trial

— CAIMAN  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03219242
• Other study ID #: 25543/16
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 29, 2017
• Last updated: January 11, 2018
• Start date: June 30, 2016
• Est. completion date: January 30, 2018

Study information

• Verified date: January 2018
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: January 30, 2018
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart Rome,	Rome,	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time-sparing for bowel resection	Time needed for bowel resection and radical omentecomy in avanced ovarian cancer	up to 1 hour
Primary	Post surgical complications	F-up in 1-3 and 6 months with questionnaire	Up to 6 months