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Functional outcome and safety of hypothermic robot-assisted radical prostatectomy using BelloCool™

Functional outcome and safety of hypothermic robot-assisted radical prostatectomy using BelloCool™: A randomized control, multicenter, single-blinded trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006926
Enrollment
200
Registered
2022-01-14
Start date
2021-04-07
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 200ml or more of sterile saline is injected into a cooling saline bag, and after pre-cooling, patient anesthesia, and positioning, jelly is applied and inserted into the rectum while

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with histopathologically diagnosed prostate cancer Clinical stage with T1-T3aN0M0 ECOG Performance status is 0-1 Patients planning to preserve bilateral neurobascular bundle (Tewari’s grade 1-2 OR Patel’s grade 3-5) Patients who can read and consent to informed consent

Exclusion criteria

Exclusion criteria: Patients who have received prior treatment for prostate cancer, such as radiation therapy, chemotherapy, or hormone therapy, before surgery or are planned after surgery Those who have had previous surgery or radiation therapy in the pelvic cavity Those with a previous diagnosis of urinary incontinence or neurogenic bladder Those with neurological problems such as central nervous system disease or peripheral neuropathy Those who are judged by the investigator to be inappropriate to participate in other clinical trials

Design outcomes

Primary

MeasureTime frame
Proportion of patients using less than 1 pad at 6 months

Secondary

MeasureTime frame
Urinary incontinence recovery status over time, erection recovery status over time, inflammation-related values ??on the first day after surgery, and complications at 90 days after surgery

Countries

Korea, Republic of

Contacts

Public ContactJae Hoon Chung

Samsung Medical Center

dr.jhchung@gmail.com+82-2-3410-3558

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026