Prospective Randomized Controlled Study Comparing Peak Expiratory Flow (PEF) Changes After Robot-Assisted and Open Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in PEF (L/min)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Outcomes
Primary Outcomes
Change in PEF (L/min)
Time Frame: From preoperative baseline to postoperative 2nd hour
Difference between preoperative and early postoperative PEF values.
Secondary Outcomes
- Incidence of respiratory complications(Within the first 24 hours after surgery)
- Change in PEF from preoperative to postoperative 24th hour(From preoperative measurement (baseline) to postoperative 24th hour)
- Intraoperative parameters correlated with PEF reduction(From induction of anesthesia to end of surgery)
Investigators
Betül Güven
Principal Investigator
Ankara City Hospital Bilkent