Condition category
Surgery
Date applied
13/12/2005
Date assigned
07/02/2006
Last edited
03/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes