PORT-cAtheter-System implantation: a randomised controlled trial to compare two different surgical implantation techniques
| ISRCTN | ISRCTN52368201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52368201 |
| Protocol serial number | KSC 02/2005 |
| Sponsor | University of Heidelberg (Germany) |
| Funder | University of Heidelberg (Germany) - Department of Surgery |
- 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
Scientific
Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 566200 |
|---|---|
| Markus.Buechler@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre intra-operatively randomised controlled superiority trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Primary success rate of both implantation techniques. |
| Key secondary outcome measure(s) |
1. Duration of the procedure |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| 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
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | Yes | No | |
| Protocol article | protocol | 08/06/2006 | Yes | No |
