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The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon |
|
| B | Experimental | Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venae sectio | Procedure | surgical preparation of the cephalic vene to insert a totally implantable access port. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary success rate of the randomized intervention | Assessed on the day of surgery (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-/postoperative complication rate for the randomized intervention | Assessed after 90 day post operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus W Büchler, Prof. Dr. | University of Heidelberg, Department of General, Visceral and Transplantation Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg | Heidelberg | Baden Würtemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21412146 | Derived | Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21. | |
| 18950491 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Punction of V. subclavia | Procedure | radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port |
|
| Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. 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. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60. |