Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peak Expiratory Flow | — | UNRESOLVED | — |
| Prostate Cancer (CRPC) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical procedure: Robot-assisted laparoscopic radical prostatectomy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open Radical Prostatectomy (Control Group)
- description
- Patients undergoing open radical prostatectomy under standardized general anesthesia. No pneumoperitoneum or steep Trendelenburg position is applied.
- interventionNames
- Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy
- type
- EXPERIMENTAL
- label
- Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group)
- description
- Patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) under standardized general anesthesia, with carbon dioxide pneumoperitoneum and Trendelenburg positioning.
- interventionNames
- Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available