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

Completed

• Conditions: Cancer

• Registration Number: NCT00921141
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-04
• Study Completion: 2009-04
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 815

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Brief description of the different risk factor for morbidity	Until the implantable central venous access ports removal
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
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

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France