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
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 April 20, 2014