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

November 23, 2025 updated by: Betül Güven, Ankara City Hospital Bilkent

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye)
        • Ankara Bilkent City Hospital, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open Radical Prostatectomy (Control Group)
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
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.
Experimental: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PEF (L/min)
Time Frame: From preoperative baseline to postoperative 2nd hour
Difference between preoperative and early postoperative PEF values.
From preoperative baseline to postoperative 2nd hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From preoperative measurement (baseline) to postoperative 24th hour
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.
From induction of anesthesia to end of surgery
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.
Within the first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: betül aytaç, Ankara Bilkent City Hospital, Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED1-25-1680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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