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

Cancer Clinical Trial

— CCI  

Official title:

Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921141
• Other study ID #: CCI
• Secondary ID: CCI
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: July 20, 2012
• Start date: May 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: April 2009
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change		Until the implantable central venous access ports removal	No
Secondary	Brief description of the different risk factor for morbidity		Until the implantable central venous access ports removal	No
Secondary	Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features		Until the implantable central venous access ports removal	No
Secondary	Assessment of the patient quality of life		Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy	No