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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer (CRPC) Peak Expiratory Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Open Radical Prostatectomy (Control Group)

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

Group Type ACTIVE_COMPARATOR

Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

Intervention Type DIAGNOSTIC_TEST

RALRP 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.

Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group)

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

Group Type EXPERIMENTAL

Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

Intervention Type DIAGNOSTIC_TEST

RALRP 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.

Interventions

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Surgical procedure: Robot-assisted laparoscopic radical prostatectomy

RALRP 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No