Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

NCT00600444

Cancer

COMPLETED NA

Functional Evaluation of Two Types of Totally Implanted Venous Ports

NCT00484848

Hematologic Disease

COMPLETED NA

Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

NCT01971021

Focus of Study

COMPLETED NA

Femoral or Radial Approach in Coronary Chronic Total Occlusion

NCT03265769

Chronic Coronary Occlusion

COMPLETED NA

Use of the Venous Coupler in Breast Reconstruction by Means of a Deep Inferior Epigastric Perforator: Reduction of Surgery Length and Venous Thromboses ?

NCT03340623

Mammary Reconstruction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Venous Access Devices Implantable Venous Access Port

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transversely incision

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

Group Type ACTIVE_COMPARATOR

Incision

Intervention Type 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

longitudinally incision

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,

Group Type ACTIVE_COMPARATOR

Incision

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Incision

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Age \> 18 and \< 80 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No