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Active, not recruiting Not applicable

Comparison of Peak Expiratory Flow Changes After Robot-Assisted Versus Open Radical Prostatectomy

NCT07262073 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2025-12-03

Condition(s) studied

Prostate Cancer (CRPC)Peak Expiratory Flow

Investigational drug(s) / intervention(s)

Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

Surgical procedure: Robot-assisted laparoscopic radical prostatectomy: RALRP will be performed with pneumoperitoneum (12-15 mmHg CO₂ insufflation) and 25-30° Trendelenburg position. Peak Expiratory Flow (PEF) will be measured preoperatively, 2 hours postoperatively, and 24 hours postoperatively using the same handheld peak flow meter.

Study summary

This prospective, randomized controlled trial aims to compare perioperative respiratory changes in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) and open radical prostatectomy (ORP). The primary outcome is the change in peak expiratory flow (PEF) from the preoperative period to the early postoperative (2nd hour) period. Secondary outcomes include PEF recovery at 24 hours, and correlations between PEF change and intraoperative factors such as Trendelenburg angle, pneumoperitoneum duration, and ventilatory parameters.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male, 18-80 years old * ASA physical status I-III * Scheduled for open or robot-assisted radical prostatectomy * Able to provide informed consent and follow Turkish instructions Exclusion Criteria: * Moderate/severe COPD (GOLD II-IV) * Active upper respiratory tract infection * Severe OSA requiring CPAP * Inability to perform standardized PEF maneuver * Emergency surgery * Cognitive impairment preventing participation

Primary outcome measure(s)

  • Change in PEF (L/min) — From preoperative baseline to postoperative 2nd hour
    Difference between preoperative and early postoperative PEF values.

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital, Department of Anesthesiology Ankara Çankaya
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262073 on ClinicalTrials.gov ↗ ← All trials in Turkey