PORT-cAtheter-System implantation: a randomised controlled trial to compare two different surgical implantation techniques

ISRCTN	ISRCTN52368201
DOI	https://doi.org/10.1186/ISRCTN52368201
Secondary identifying numbers	KSC 02/2005

Submission date: 13/12/2005
Registration date: 07/02/2006
Last edited: 03/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Markus W. Buechler
Scientific

Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)6221 566200
Email	Markus.Buechler@med.uni-heidelberg.de

Study information

Study design	Single-centre intra-operatively randomised controlled superiority trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	PORTAS
Study objectives	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(s)	Local Ethics Commission approved 12th December 2005
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2006
Completion date	01/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160 patients
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/06/2007

Locations

Countries of recruitment

Germany

Study participating centre

Department of Surgery

Heidelberg
69120
Germany

Sponsor information

University of Heidelberg (Germany)
University/education

Department of Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)6221 566200
Email	Markus.Buechler@med.uni-heidelberg.de
"ROR"	https://ror.org/038t36y30

Funders

Funder type

University/education

University of Heidelberg (Germany) - Department of Surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/06/2006		Yes	No
Results article	results	01/02/2009		Yes	No