None listed
Conditions
Interventions
Medical Device : 1. Pre-cooling before surgery by injecting more than 200ml of sterile saline into the saline bag for cooling.
2. After anesthesia and positioning of the patient, apply and insert 100
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patients diagnosed with prostate cancer who are planning to undergo robotic assisted radical prostatectomy - Patients with 12 or more IIEF-5 score before surgery - Activity level of normal daily life (Eastern Cooperative Oncology Group performance status of 0 or 1) - Patients who can read and agree to the consent form - Men with 19-year-old or more and under 80
Exclusion criteria
Exclusion criteria: - Those who have received prior treatment or planned after surgery for prostate cancer such as radiation therapy, chemotherapy, hormonal therapy before surgery - Previous surgery or radiotherapy in the pelvic cavity - Those who do not wish to attend this study - A person who is considered inappropriate to participate in the clinical trial in the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of scheduled operation and pelvic hypothermia therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| IIEF-5, EPIC-CP, EQ-5D-5L measurement;Comparison of physical inflammatory response through change of CRP, ESR, CBC;Evaluation of incontinence status and erection status;Safety evaluation;Efficacy measurement of hypothermia induction in pelvic hypothermia therapy | — |
Countries
Korea, Republic of
Contacts
Public ContactHwanik Kim
Seoul National University Hospital
Outcome results
None listed