Peak Expiratory Flow, Prostate Cancer (CRPC)
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTSurgical 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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PEF (L/min) | From preoperative baseline to postoperative 2nd hour | Difference between preoperative and early postoperative PEF values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PEF from preoperative to postoperative 24th hour | From preoperative measurement (baseline) to postoperative 24th hour | Evaluates recovery of PEF compared to baseline. |
| Intraoperative parameters correlated with PEF reduction | From induction of anesthesia to end of surgery | Correlation between PEF change and intraoperative variables including Trendelenburg angle/duration, pneumoperitoneum pressure/duration, ventilatory pressures, and intraoperative fluid balance. |
| Incidence of respiratory complications | Within the first 24 hours after surgery | Frequency of postoperative respiratory events such as desaturation, need for reintubation, or presence of chemosis. |
Countries
Turkey (Türkiye)
Outcome results
None listed