Skip to content

Role of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection; prospective randomised study.

Role of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy with extended pelvic lymph node dissection; prospective randomised study. - Role of pelvic drain placement vs no pelvic drain placement after RARP with ePLND; prospective randomised study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054032
Enrollment
140
Registered
2024-04-01
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Prostate cancer

Interventions

No drain placement group: The patients is not placed intracorporeal drain tube after surgery. Drain placement group: The patients is placed 15 Fr drain tube at pelvic floor from incision used during R

Sponsors

Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1: Patients who are pathologically diagnosed with prostate cancer. 2: Patients who are performed robot-assisted radical prostatectomy with extended pelvic lymph node dissection. 3: Patients who are 20 years of age or older at the time consent is obtained 4: Patients who can obtain written consent for participation in this study from the individual

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate by the person in principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
The primary outcomes are the incident rates of organ space surgical site infection more than Clavien-Dindo Grade 3 within 30 days after surgery.

Secondary

MeasureTime frame
1: Any complications excluded organ space surgical site infection within 90 days after surgery. We assess complications rates and level based on Clavien-Dindo classification. 2: Cosmesis of surgical wound at the postoperative 2, 7 and 30 days. Patients assess cosmesis (0: very ugly to 10: very beautiful) on the basis of a visual analogue scale. 3: Patient's satisfaction at the postoperative 2, 7 and 30 days. Patients assess satisfaction (0: not satisfied to 10: very satisfied) on the basis of a visual analogue scale. 4: Pain at the postoperative 2, 7 and 30 days. Patients assess pain (0: not painful to 10: very painful) on the basis of a visual analogue scale.

Countries

Japan

Contacts

Public ContactTomoya Hatayama

Hiroshima University Hospital Urology

htomoya1211@hiroshima-u.ac.jp082-257-5242

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026