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Active Not RecruitingNCT07262073

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

Prospective Randomized Controlled Study Comparing Peak Expiratory Flow (PEF) Changes After Robot-Assisted and Open Radical Prostatectomy

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
Male
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSurgical procedure: Robot-assisted laparoscopic radical prostatectomyRALRP 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.

Timeline

Start date
2025-11-01
Primary completion
2025-12-30
Completion
2026-06-30
First posted
2025-12-03
Last updated
2025-12-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07262073. Inclusion in this directory is not an endorsement.