Timing of Recruitment Maneuver in Robotic Prostate Surgery (ROBPROREC1)

June 16, 2026 updated by: CIGDEM YILDIRIM GUCLU, Ankara University

Comparison of the Effects of Recruitment Maneuver Timing on Postoperative Pulmonary Complications in Patients Undergoing Robotic Prostate Surgery

Robotic prostate surgery is commonly performed under general anesthesia with carbon dioxide pneumoperitoneum and steep Trendelenburg positioning. These conditions may reduce lung volumes, impair respiratory mechanics, and increase the risk of atelectasis and postoperative pulmonary complications. Recruitment maneuvers combined with individualized positive end-expiratory pressure may improve intraoperative oxygenation and lung compliance; however, the optimal timing of recruitment maneuver application in robotic prostate surgery remains unclear.

This prospective randomized study aims to compare the effects of recruitment maneuver timing on postoperative pulmonary complications in adult patients undergoing elective robotic prostate surgery. Participants will be randomized into two groups. In the Supine Recruitment Group, the recruitment maneuver will be performed before carbon dioxide insufflation while the patient is in the supine position, followed by individualized PEEP determination. In the Trendelenburg Recruitment Group, the recruitment maneuver will be performed after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination. Patients will be evaluated for postoperative pulmonary complications up to postoperative 72 hours or until discharge, whichever occurs first.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic and robotic surgeries performed with carbon dioxide insufflation may cause clinically relevant physiological changes affecting pulmonary function. Pneumoperitoneum increases intra-abdominal pressure and, together with Trendelenburg positioning, may reduce functional residual capacity, decrease lung compliance, and promote atelectasis. These changes may contribute to hypoxemia and postoperative pulmonary complications.

Recruitment maneuvers are used to reopen collapsed alveolar units and may improve oxygenation and respiratory mechanics when combined with appropriate PEEP. Decremental PEEP titration is one method used to determine an individualized PEEP level after a recruitment maneuver by gradually reducing PEEP while monitoring oxygenation, respiratory compliance, and hemodynamic parameters.

The present study will evaluate whether the timing of recruitment maneuver application affects postoperative pulmonary outcomes in patients undergoing robotic prostate surgery. The study will compare recruitment maneuver performed before insufflation in the supine position with recruitment maneuver performed after insufflation and Trendelenburg positioning. Both groups will undergo individualized PEEP determination after the recruitment maneuver.

Study Type

Interventional

Enrollment (Estimated)

86

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

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:

  • Patients scheduled for elective robotic prostate surgery
  • Age 18 years or older
  • Body mass index between 18 and 35 kg/m²
  • No cognitive impairment
  • Ability to provide written informed consent

Exclusion Criteria:

  • Age younger than 18 years
  • Emergency surgery
  • Preoperative oxygen requirement
  • Cognitive impairment
  • Refusal to participate in the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supine Recruitment Group
After routine ASA monitoring and induction of general anesthesia, patients will receive a recruitment maneuver before carbon dioxide insufflation while in the supine position. Individualized PEEP will then be determined using decremental PEEP titration.
Procedure: Recruitment maneuver in the supine position
The recruitment maneuver will be performed while the patient is in the supine position, before pneumoperitoneum insufflation and Trendelenburg positioning during robotic prostate surgery. The maneuver will be applied according to the predefined intraoperative ventilation protocol to improve alveolar recruitment and reduce postoperative pulmonary complications.
Active Comparator: Trendelenburg Recruitment Group
After routine ASA monitoring and induction of general anesthesia, carbon dioxide insufflation and Trendelenburg positioning will be performed. The recruitment maneuver will then be applied, followed by individualized PEEP determination using decremental PEEP titration.
Procedure: Recruitment maneuver after insufflation and Trendelenburg positioning
A lung recruitment maneuver will be applied after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination using decremental PEEP titration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative pulmonary complications
Time Frame: From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.
Postoperative pulmonary complications will be evaluated after surgery, including clinically relevant pulmonary events such as atelectasis, hypoxemia, respiratory infection, bronchospasm, aspiration pneumonitis, respiratory failure, need for noninvasive or invasive ventilatory support, or other predefined pulmonary complications according to the study protocol.
From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From the day of surgery to hospital discharge, assessed up to 30 days.
Duration of hospital stay will be recorded in days from the day of surgery to hospital discharge.
From the day of surgery to hospital discharge, assessed up to 30 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative respiratory system compliance and oxygenation
Time Frame: Intraoperative period
Respiratory system compliance will be recorded during mechanical ventilation at predefined intraoperative time points.
Intraoperative period

Collaborators and Investigators

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

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

May 9, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROBPROREC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data privacy regulations and participant confidentiality.

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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