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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00921141 |
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Date of registration:
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15/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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815 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00921141 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Fabrice NARDUCCI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Oscar Lambret |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Brief description of the different risk factor for morbidity
[Time Frame: Until the implantable central venous access ports removal]
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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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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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