Comparison of Peak Expiratory Flow Changes After Robot-Assisted Versus Open Radical Prostatectomy (NCT07262073) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Peak Expiratory Flow Changes After Robot-Assisted Versus Open Radical Prostatectomy
Turkey (Türkiye)60 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PEF (L/min)
Timeframe: From preoperative baseline to postoperative 2nd hour