Linked Life Data

18950491

Source:http://linkedlifedata.com/resource/pubmed/id/18950491

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2008-11-6
pubmed:abstractText
BACKGROUND: Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae Sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient. DESIGN: A single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the informed consent will be included. The primary endpoint is the primary success rate of the randomized technique. Control Intervention: Venae Sectio will be employed to insert a TIAP by a surgeon; Experimental intervention: Punction of V. Subclavia will be used to place a TIAP by a radiologist. Duration of study: Approximately 10 months, follow up time: 90 days. ORGANISATION/RESPONSIBILITY: The PORTAS 2 - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI), University of Heidelberg. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT00600444).
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-10229476, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-10947017, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-11443406, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-11529829, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-1609072, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-16353193, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-2121966, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-2802390, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-3336827, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-6508024, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-6853618, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-8104491, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-9083981, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-9399468, http://linkedlifedata.com/resource/pubmed/commentcorrection/18950491-9711285
pubmed:language
eng
pubmed:journal
pubmed:status
PubMed-not-MEDLINE
pubmed:issn
1745-6215
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
9
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
60
pubmed:year
2008
pubmed:articleTitle
Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients.
pubmed:affiliation
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. philip.knebel@med.uni-heidelberg.de
pubmed:publicationType
Journal Article