NCT07662642

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 11, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Robotic prostate surgeryRecruitment maneuverPneumoperitoneumTrendelenburg positionPositive end-expiratory pressureAtelectasisPostoperative pulmonary complicationsGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative pulmonary complications

    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 Outcomes (1)

  • Length of hospital stay

    From the day of surgery to hospital discharge, assessed up to 30 days.

Other Outcomes (1)

  • Intraoperative respiratory system compliance and oxygenation

    Intraoperative period

Study Arms (2)

Supine Recruitment Group

EXPERIMENTAL

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

Trendelenburg Recruitment Group

ACTIVE COMPARATOR

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

Interventions

A lung recruitment maneuver will be applied after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination using decremental PEEP titration.

Trendelenburg Recruitment Group

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.

Supine Recruitment Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24.

    PMID: 20150855BACKGROUND
  • Sumer I, Topuz U, Alver S, Umutoglu T, Bakan M, Zengin SU, Coskun H, Salihoglu Z. Effect of the "Recruitment" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery. Obes Surg. 2020 Jul;30(7):2684-2692. doi: 10.1007/s11695-020-04551-y.

    PMID: 32207048BACKGROUND
  • Futier E, Constantin JM, Pelosi P, Chanques G, Kwiatkoskwi F, Jaber S, Bazin JE. Intraoperative recruitment maneuver reverses detrimental pneumoperitoneum-induced respiratory effects in healthy weight and obese patients undergoing laparoscopy. Anesthesiology. 2010 Dec;113(6):1310-9. doi: 10.1097/ALN.0b013e3181fc640a.

    PMID: 21068660BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary AtelectasisPostoperative ComplicationsPneumoperitoneum

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors were masked to group allocation. The anesthesiologist performing the recruitment maneuver was not masked because of the nature of the intervention.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 23, 2026

Study Start

May 9, 2026

Primary Completion

July 15, 2026

Study Completion

July 20, 2026

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

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