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Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port


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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 B├╝chler, 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

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