Contact information
Type
Scientific
Primary contact
Prof Markus W. Buechler
ORCID ID
Contact details
Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 566200
Markus.Buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KSC 02/2005
Study information
Scientific title
Acronym
PORTAS
Study hypothesis
The primary objective is to show whether a modified Seldinger technique is superior to the conventional surgical approach in implanting a port-catheter-system with less failures than the prior strategy. The modified Seldinger technique consists of a set including an introducer, a guide wire and a pull-away-sheath to place the catheter correctly.
Ethics approval
Local Ethics Commission approved 12th December 2005
Study design
Single-centre intra-operatively randomised controlled superiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Port-catheter-system implanting
Intervention
Patients with benign or malignant diseases who demand a safe and permanent venous access e.g. for chemotherapy and/or parenteral nutrition, will be randomised to:
Group 1: A modified Seldinger-technique with a guide wire, dilatator and a pull-away-sheath is used after preparation of the cephalic vein to place the catheter
Group 2: Conventional venae section technique is used. The catheter will be inserted directly without a pull-away-sheath or a guide wire.
Please note that this trial was successfully completed in May 2007.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Primary success rate of both implantation techniques.
Secondary outcome measures
1. Duration of the procedure
2. Rate of peri- or post-operative complications
Overall trial start date
01/01/2006
Overall trial end date
01/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or more, either sex
2. Patients scheduled for primary elective implantation of a port-catheter-system under local anaesthesia
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160 patients
Participant exclusion criteria
1. Participation in another interventional-trial with possible interference in the outcome or interventions in this study
2. Lack of compliance
3. Impaired mental state or language problems
Recruitment start date
01/01/2006
Recruitment end date
01/06/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Surgery
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg (Germany)
Sponsor details
Department of Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 566200
Markus.Buechler@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Heidelberg (Germany) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16762049
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19160366
Publication citations
-
Protocol
Knebel P, Fröhlich B, Knaebel HP, Kienle P, Luntz S, Buchler MW, Seiler CM, Comparison of Venae Sectio vs. modified Seldinger Technique for totally implantable access ports; Portas-trial [ISRCTN:52368201]., Trials, 2006, 7, 20, doi: 10.1186/1745-6215-7-20.
-
Results
Knebel P, Fischer L, Huesing J, Hennes R, Büchler MW, Seiler CM, Randomized clinical trial of a modified Seldinger technique for open central venous cannulation for implantable access devices., Br J Surg, 2009, 96, 2, 159-165, doi: 10.1002/bjs.6457.