Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports (CCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00921141
First received: June 15, 2009
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

This is a prospective, descriptive and observational study of the anticancer center practice


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change [ Time Frame: Until the implantable central venous access ports removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief description of the different risk factor for morbidity [ Time Frame: Until the implantable central venous access ports removal ] [ Designated as safety issue: No ]
  • Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features [ Time Frame: Until the implantable central venous access ports removal ] [ Designated as safety issue: No ]
  • Assessment of the patient quality of life [ Time Frame: Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 815
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
study population
Patient with cancer requiring a long-term central venous catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All the patients requiring the implementation of a catheter in an anticancerous center

Criteria

Inclusion Criteria:

  • Patient with any cancer, requiring a central venous catheter
  • No contraindication for any surgery with local or complete anaesthesia

Exclusion Criteria:

  • Previous Xylocaine or Lidocaine allergy
  • Clinic superior vena cava syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921141

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Fabrice NARDUCCI, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00921141     History of Changes
Other Study ID Numbers: CCI, CCI
Study First Received: June 15, 2009
Last Updated: July 20, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Centre Oscar Lambret:
Implantable central venous access ports, cancer

ClinicalTrials.gov processed this record on August 19, 2014