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

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ClinicalTrials.gov Identifier: NCT00921141
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease
Cancer

Study Type : Observational
Actual Enrollment : 815 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2009

Group/Cohort
study population
Patient with cancer requiring a long-term central venous catheter



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Brief description of the different risk factor for morbidity [ Time Frame: Until the implantable central venous access ports removal ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921141


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

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00921141     History of Changes
Other Study ID Numbers: CCI
CCI
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012

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