Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272623
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2006-01-03
Brief Title:
Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Seldinger Technique Versus Venous Cut-Down for Placement of Totally Implantable Venous Access Ports
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since the first placement of a totally implantable venous access port TIVAP by Niederhuber et al in 1982 its application to provide long-term central venous access has dramatically increased These systems have dramatically simplified the administration of chemotherapy and parenteral nutrition as well as the repetitive collection of blood samples
Initial retrospective studies have focused on the complications associated with different implantation techniques Subsequently major attention has been payed to the comparison of distinct types of TIVAPs To date a variety of approved port systems are available These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective randomized trials directly comparing these two approaches are still lacking So the choice which technique to use is left to the surgeons preference
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate operation time and perioperative morbidity
Initial retrospective studies have focused on the complications associated with different implantation techniques Subsequently major attention has been payed to the comparison of distinct types of TIVAPs To date a variety of approved port systems are available These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective randomized trials directly comparing these two approaches are still lacking So the choice which technique to use is left to the surgeons preference
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate operation time and perioperative morbidity
Detailed Description:
Since the first placement of a totally implantable venous access port TIVAP by Niederhuber et al in 1982 its application to provide long-term central venous access has dramatically increased These systems have dramatically simplified the administration of chemotherapy and parenteral nutrition as well as the repetitive collection of blood samples
Initial retrospective studies have focused on the complications associated with different implantation techniques Subsequently major attention has been payed to the comparison of distinct types of TIVAPs To date a variety of approved port systems are available These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective randomized trials directly comparing these two approaches are still lacking So the choice which technique to use is left to the surgeons preference
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate operation time and perioperative morbidity
After an informed consent has been obtained patients will be randomized as follows By means of sealed envelopes a total of 152 patients will be allocated either to TIVAP placement using Seldinger technique or by venous cut down n 76 in each group
Operations will be performed in local or general anaesthesia either on an outpatient basis or via 24h-admission Changes of technique due to catheter implantation failure operation time and intraoperative complications will be assessed during the procedure Postoperative examination will be standardized in both groups ie chest radiography to confirm catheter placement and to exclude pneumothorax as well as final clinical examination at discharge or before patient transfer
Initial retrospective studies have focused on the complications associated with different implantation techniques Subsequently major attention has been payed to the comparison of distinct types of TIVAPs To date a variety of approved port systems are available These devices can be either implanted using the Seldinger technique or by venous cut-down of the cephalic vein Despite the global use of these established implantation procedures prospective randomized trials directly comparing these two approaches are still lacking So the choice which technique to use is left to the surgeons preference
The aim of this study is to directly compare the Seldinger technique versus cephalic vein cut down for placement of TIVAPs in respect of implantation success rate operation time and perioperative morbidity
After an informed consent has been obtained patients will be randomized as follows By means of sealed envelopes a total of 152 patients will be allocated either to TIVAP placement using Seldinger technique or by venous cut down n 76 in each group
Operations will be performed in local or general anaesthesia either on an outpatient basis or via 24h-admission Changes of technique due to catheter implantation failure operation time and intraoperative complications will be assessed during the procedure Postoperative examination will be standardized in both groups ie chest radiography to confirm catheter placement and to exclude pneumothorax as well as final clinical examination at discharge or before patient transfer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None