Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess whether the direction of skin incision affects pain within the first 24 hours, patient comfort 7 days after the procedure, procedure time, and the occurrence of early complications related to vascular port implantation.
The vascular port implantation procedure is used in patients who require long-term access to veins, e.g. during chemotherapy, long-term drug administration or blood collection. This procedure is performed under local anesthesia, by cannulating the internal jugular vein - left or right and making an incision to place the port on the chest wall (so-called "pocket") in the subclavicular area on the side of the cannulated vein.
Vessel cannulation is performed percutaneously using an ultrasound machine and fluoroscopy. The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision can be made transversely or longitudinally, depending on the preferences of the physician performing the procedure. In both cases, this does not affect the further course of the procedure. Both methods of creating a vascular "pocket" are commonly used. The procedures are performed as part of one-day stays, and after the procedure, patients are discharged home.
To the best of our knowledge, this is the first study that will compare the direction of the skin incision. In our study, we wanted to compare pain in the first 24 hours, patient comfort after 7 days of the procedure, procedure time, occurrence of early complications related to vascular port implantation. Patients undergoing the vascular port implantation procedure will be divided into two groups, one will have a transverse incision, and the other a longitudinal incision in order to place the port in the subcutaneous tissue. Patients will receive a questionnaire to fill out (in the appendix to the application) and will have their pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure. Additionally, on the 7th day after the procedure, I will be asked to assess any discomfort associated with the presence of the vascular port on a scale of 0-5. Data will be collected by phone. Additionally, we will measure the procedure time and occurrence of any complications related to port implantation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transversely incision | Active Comparator | The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision will be made transversely |
|
| longitudinally incision | Active Comparator | The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision will be made longitudinally, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incision | Procedure | The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision can be made transversely or longitudinally |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort | discomfort associated with the presence of the vascular port on a scale of 0-5 | 7 days |
Not provided
Inclusion Criteria:
Age > 18 and < 85 years Informed consent Need for central venous access port implementation under local anesthesia
Exclusion Criteria:
Impaired blood clotting Ongoing antiplatelet drugs therapy, except acetylsalicylic acid Trauma or surgical past history on both shoulder girdles Known central venous thrombosis (subclavian vein, upper vena cava) Known pneumothorax Chronic opioid use Septic state Agranulocytosis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University | Cracow | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36687176 | Result | Erdemir A, Rasa HK. Impact of central venous port implantation method and access choice on outcomes. World J Clin Cases. 2023 Jan 6;11(1):116-126. doi: 10.12998/wjcc.v11.i1.116. | |
| 21922348 | Result | Walser EM. Venous access ports: indications, implantation technique, follow-up, and complications. Cardiovasc Intervent Radiol. 2012 Aug;35(4):751-64. doi: 10.1007/s00270-011-0271-2. Epub 2011 Sep 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Vessel cannulation is performed percutaneously using an ultrasound machine and fluoroscopy. The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision can be made transversely or longitudinally, depending on the preferences of the physician performing the procedure. In both cases, this does not affect the further course of the procedure. Both methods of creating a vascular "pocket" are commonly used. The procedures are performed as part of one-day stays, and after the procedure, patients are discharged home.
Not provided
Not provided
Not provided
| 42380671 | Derived | Drygalski T, Zmuda A, Maciejewski P, Skladzien T, Cicio M, Kwinta A, Szpunar W, Terlecki M, Woron J, Lonc T. Transverse versus longitudinal skin incisions for totally implantable venous access port implantation: a randomized controlled trial. Langenbecks Arch Surg. 2026 Jun 30. doi: 10.1007/s00423-026-04122-2. Online ahead of print. |