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Recruiting NCT07662642

Timing of Recruitment Maneuver in Robotic Prostate Surgery

No phase Interventional Robotic Surgery Urologic Surgical Procedures Postoperative Pulmonary Complications (PPCs) Pulmonary Atelectasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recruitment maneuver after insufflation and Trendelenburg positioning, Recruitment maneuver in the supine position.
Who it may be relevant to
Registry conditions: Robotic Surgery, Urologic Surgical Procedures, Postoperative Pulmonary Complications (PPCs), Pulmonary Atelectasis. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Incidence of postoperative pulmonary complications [Time frame: From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.]
Secondary outcome measures (1)
  • Length of hospital stay [Time frame: From the day of surgery to hospital discharge, assessed up to 30 days.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 1 center
  • Ankara University Faculty of Medicine — Ankara

Publications

  • Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24. PMID 20150855
  • 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 32207048
  • 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 21068660

Identifiers

NCT: NCT07662642 · ROBPROREC1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗