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

Ankara City Hospital

Status: Active, not recruiting

Conditions: Prostate Cancer (CRPC); Peak Expiratory Flow

Treatments: Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07262073

TABED1-25-1680

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Open Radical Prostatectomy (Control Group)

Active Comparator group

Description:

Patients undergoing open radical prostatectomy under standardized general anesthesia. No pneumoperitoneum or steep Trendelenburg position is applied.

Treatment:

Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group)

Experimental group

Description:

Patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) under standardized general anesthesia, with carbon dioxide pneumoperitoneum and Trendelenburg positioning.

Treatment:

Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy