Impact of Intra-abdominal Pressure on Postoperative Recovery After Robot-Assisted Radical Prostatectomy (PICO-RALP)

Impact of Intra-abdominal Pressure on Postoperative Recovery After Robot-Assisted Radical Prostatectomy (PICO-RALP) - PICO-RALP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038240

Enrollment

100

Registered

2025-10-24

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

C61

Interventions

Group 1: Patients with radical prostatectomy and an intraabdominal pressure of 15mmHg Group 2: Patients with radical prostatectomy and an intraabdominal pressure of 10mmHg

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Histopathologically confirmed prostate cancer in stages pT1/cT2-cT3, cN0, cM0, Gleason score 6-10 • Curative therapy using RALP • Eastern Cooperative Oncology Group (ECOG) score 0-2 • BMI 18-30 • Suitability of the patient for RALP • >18 years of age • Ability to understand the nature and individual consequences of the study • Written consent

Exclusion criteria

Exclusion criteria: • Metastatic or locally advanced prostate cancer (cT4, cN+, cM+) • ECOG > 2 • Participation in another clinical trial that interferes with the outcome of this trial • Severe intestinal disease (e.g., chronic inflammatory) • Previous abdominal surgery, except: laparoscopic appendectomy, hernia repair, cholecystectomy • Nicotine abuse • Previous TURP (transurethral resection of the prostate) • Chronic lung disease • Chronic kidney disease (stage 3 according to KDGIO or higher) • Indication for therapeutic anticoagulation

Design outcomes

Primary

Measure	Time frame
Postoperative plasma IL-6 levels within the first 24h after surgery measured at variable timepoints during and after surgery as a marker of systemic inflammation	—

Secondary

Measure	Time frame
• Postoperative pain (NRS and analgesic requirement) • Cognitive function (MoCA scores preoperatively, and on Days 1, 3, and 5) • Gastrointestinal function (bowel sounds, defecation, laxative use) • Renal and hepatic function (routine labs: creatinine, AST, ALT, LDH, bilirubin) • Postoperative molecular markers for inflammation and organ dysfunction (see below) • Urine output, oxygen saturation, vesico-urethral anastomosis function • Length of hospital stay, postoperative complications (Clavien-Dindo)	—

Measure

Time frame

• Postoperative pain (NRS and analgesic requirement) • Cognitive function (MoCA scores preoperatively, and on Days 1, 3, and 5) • Gastrointestinal function (bowel sounds, defecation, laxative use) • Renal and hepatic function (routine labs: creatinine, AST, ALT, LDH, bilirubin) • Postoperative molecular markers for inflammation and organ dysfunction (see below) • Urine output, oxygen saturation, vesico-urethral anastomosis function • Length of hospital stay, postoperative complications (Clavien-Dindo)

—

Countries

Germany

Contacts

Public ContactChristian Bolenz

Klinik für Urologie und Kinderurologie

christian.bolenz@uniklinik-ulm.de+49 731 500 58000

Outcome results

None listed

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