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

NCT07262073 | Active Not Recruiting

• 1 other identifier: TABED1-25-1680
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer (CRPC); Peak Expiratory Flow

Outcome Measures

Primary Outcomes (1)

• Change in PEF (L/min)

  Difference between preoperative and early postoperative PEF values.

  From preoperative baseline to postoperative 2nd hour

Secondary Outcomes (3)

• Change in PEF from preoperative to postoperative 24th hour

  From preoperative measurement (baseline) to postoperative 24th hour

• Intraoperative parameters correlated with PEF reduction

  From induction of anesthesia to end of surgery

• Incidence of respiratory complications

  Within the first 24 hours after surgery

Study Arms (2)

Open Radical Prostatectomy (Control Group)

ACTIVE COMPARATOR

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

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

Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group)

EXPERIMENTAL

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

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

Interventions

Surgical procedure: Robot-assisted laparoscopic radical prostatectomy 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.

Open Radical Prostatectomy (Control Group); Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Department of Anesthesiology

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• betül aytaç

  Ankara Bilkent City Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 3, 2025
• Study Start: November 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-10

Locations

TU (1)