The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.
After being informed about the study, all patients give writted informed consent. After that they will be randomized in two groups (A with drainage, B without drainage) using a random sequence generator. Then the patient will undergo the implantation of a three-component penile prosthesis following peri antibiotic prophylaxis with cephalosporins and aminoglycosides, the antibiotic prophylaxis will be continued on the first post-operative day surgery with a cephalosporin. In the group A it will be positioned at the scrotal level (using surgical access or using a second incision) an external drainage (10 Ch in aspiration) for 24 hours. The drainage will be removed on the first post-operative day. The degree of the hematoma will be determined using a 5-point Likert scales already approved in previous cases. Subsequently patients will carry out periodic check-ups at 7, 15 and 30 days after the operation to evaluate the appearance of hematomas and surgical site infection. After that, they will carry out check-ups every month for the first 3 months, then every 3 months for the first year and finally annually up to the fifth year after the intervention. During the clinical check-ups, it will also be defined the time of use of the penile prosthesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Application of external scrotal drainage during three-component penile prosthesis placement
SCDU Urologia
Torino, Torino, Italy
NOT_YET_RECRUITINGA.O.U. Città della Salute e della Scienza di Torino
Turin, Turin, Italy
RECRUITINGPost-operative infectious episodes
Define the number of post-operative infectious episodes in the two study arms.
Time frame: One month
Post-surgical hematoma
Define the risk of post-surgical hematoma formation in the two study arms.
Time frame: One month
Volume of drained material
Evaluate the volume of drained material in the group with external drainage.
Time frame: 24 hour
Manipulation of the activation pump
Define the time elapsed between surgery and subsequent manipulation of the activation pump in the two study arms, usually 2 weeks.
Time frame: Up to 12 weeks
Activation of the device
Define the time elapsed between the surgical intervention and the subsequent activation of the device in the two study arms, usually 3 weeks.
Time frame: Up to 12 weeks
Use of the penile prosthesis
Define the time elapsed between surgery and the use of the penile prosthesis for sexual activity in the two study arms, usually 4 weeks after surgery.
Time frame: Up to 12 weeks
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the IIEF questionnaires.
Time frame: Up to 12 months
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Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the SSIPI questionnaires.
Time frame: Up to 12 months
Effectiveness of external drainage in subgroups
Compare, through a sub-analysis, the effectiveness of external drainage in different patient populations: heart patients, diabetics, duration of surgery. We will test the effectiveness of external drainage in these soubgroups using the QoLPSS questionnaires.
Time frame: Up to 12 months