Trial Information
Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
Inclusion Criteria:
- Age equal or greater than 18 years
- Patients scheduled for primary elective implantation of TIAP
Exclusion Criteria:
- Participation in another clinical trial which could interfere with the primary
endpoint of this study
- Lack of compliance
- Impaired mental state or language problem
- Patients with known allergy to contrast agent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary success rate of the randomized intervention
Outcome Time Frame:
Assessed on the day of surgery (day 0)
Safety Issue:
No
Principal Investigator
Markus W Büchler, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg, Department of General, Visceral and Transplantation Surgery
Authority:
Germany: Ethics Commission
Study ID:
KSC01/08
NCT ID:
NCT00600444
Start Date:
February 2008
Completion Date:
May 2009
Related Keywords:
- Cancer
- permanent venous access
- chemotherapy
- parenteral nutrition
- Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition
- benign diseases
- malignant diseases