Background
Totally Implantable Access Ports (TIAP)
Implantation techniques
Modified Seldinger Technique (combination of Venae Sectio and Seldinger Technique)
Medical problem
Study design
Aim of study
Number of patients needed
Estimated event rate
Size of treatment effect that should be detectable
Patients needed
Eligibility
Inclusion criteria
-
Benign and malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition
-
Age equal or greater than 18 years
-
Patients scheduled for primary elective implantation of a port-catheter-system in local anaesthesia
-
Informed consent
Exclusion criteria
-
Participation in another intervention-trial with interference of intervention and outcome of this study
-
Lack of compliance
-
Impaired mental state or language problems (Patient is not able to read german texts)
Subject withdrawal criteria
-
Randomization will be carried out after preparation of the cephalic vein. If no vein is to exhibit the subject will be removed from the trial and the pre-rand drop-out is to record in the CRF
-
At their own request or at request of the legal representative
-
If, in the investigator's opinion, continuation of the trial would be detrimental to the subject's well-being
Consent
Randomization and procedures for minimizing bias
Minimizing systematic bias
Minimizing treatment bias
Minimizing measurement bias
Study treatment
Intervention-group 1
Intervention-group 2
Primary and secondary endpoints
Primary endpoint
Definition of the primary endpoint
Assessment of the primary endpoint
Secondary endpoints
-
Duration of port implantation procedure
-
Perioperative complication rate
-
Postoperative complication rate
Safety aspects
Specification of safety parameters
Training for surgeons
Concomitant medication
Past medical history
Adverse events and serious adverse events
Analysis
Study organization
-
The incidence or severity of adverse events in this trial indicates a potential health hazard caused by the study treatment
-
It appears that patient's enrolment is unsatisfactory with respect to quality and/or quantity or data recording is severely inaccurate and/or incomplete
-
External evidence that makes it necessary to terminate the trial
Financial support
To be assessed for eligibility (n = 280) | ||
Total to be excluded (n = 100) refusal to participate (n = 40) not meeting inclusion criteria prior to surgery (n = 20) no cephalic vein present (n = 20) other reasons (n = 20) | ||
To be randomized (n = 180) | ||
Experimental Group | Control Group | |
To be allocated to intervention (n = 90) receive allocated intervention (n = 80) don't receive allocated intervention (n = 10) | To be allocated to intervention (n = 90) receive allocated intervention (n = 80) do not receive allocated intervention (n = 10) | |
To be analyzed (n = 80) | To be analyzed (n = 80) |