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NCT Number: NCT07262073

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer (CRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Peak Expiratory Flow Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital, Department of Anesthesiology

Ankara, Çankaya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in PEF (L/min)

    Time frame: From preoperative baseline to postoperative 2nd hour

    Difference between preoperative and early postoperative PEF values.

Secondary outcomes

  1. Change in PEF from preoperative to postoperative 24th hour

    Time frame: From preoperative measurement (baseline) to postoperative 24th hour

    Evaluates recovery of PEF compared to baseline.

  2. Intraoperative parameters correlated with PEF reduction

    Time frame: From induction of anesthesia to end of surgery

    Correlation between PEF change and intraoperative variables including Trendelenburg angle/duration, pneumoperitoneum pressure/duration, ventilatory pressures, and intraoperative fluid balance.

  3. Incidence of respiratory complications

    Time frame: Within the first 24 hours after surgery

    Frequency of postoperative respiratory events such as desaturation, need for reintubation, or presence of chemosis.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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