Safety and efficacy of rectal cooling balloon during radical prostatectomy
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0004310
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 20
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
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion rate of scheduled operation and pelvic hypothermia therapy
- Secondary Outcome Measures
Name Time Method 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