Robotic SurgeryROBPROREC1NCT07662642
Timing of Recruitment Maneuver in Robotic Prostate Surgery
A study testing Recruitment maneuver after insufflation and Trendelenburg positioning and Recruitment maneuver in the supine position in people with Robotic Surgery and Urologic Surgical Procedures, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Robotic Surgery, Urologic Surgical Procedures, Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Recruitment maneuver after insufflation and Trendelenburg positioning and Recruitment maneuver in the supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age younger than 18 years
- Emergency surgery
- Preoperative oxygen requirement
- Cognitive impairment
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine
Ankara
Fatma Candan Yerebakan Altınışık, M.D., +905417324291, candanyerebakan@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Robotic Surgery, Urologic Surgical Procedures, Postoperative Pulmonary Complications (PPCs), Pulmonary Atelectasis, Postoperative Complications
- Being tested
- Recruitment maneuver after insufflation and Trendelenburg positioning, Recruitment maneuver in the supine position
- Keywords
- Robotic prostate surgery, Recruitment maneuver, Pneumoperitoneum, Trendelenburg position, Positive end-expiratory pressure, Atelectasis, Postoperative pulmonary complications, General anesthesia
- Medical subject headings
- Pulmonary Atelectasis, Postoperative Complications, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuver after insufflation and Trendelenburg positioningProcedure or surgery
A lung recruitment maneuver will be applied after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination using decremental PEEP titration.
Recruitment maneuver in the supine positionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Recruitment maneuver after insufflation and Trendelenburg positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.
Secondary outcomes (1)
Length of hospital stay
Duration of hospital stay will be recorded in days from the day of surgery to hospital discharge.
Measured: From the day of surgery to hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start9 May 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Robotic SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662642
- Sponsor's protocol ID
- ROBPROREC1
- Acronym
- ROBPROREC1
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data privacy regulations and participant confidentiality.
Publications
Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24.
PubMed 20150855Sumer 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.
PubMed 32207048Futier 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.
PubMed 21068660
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Recruitment Maneuver Timing on Postoperative Pulmonary Complications in Patients Undergoing Robotic Prostate Surgery
- ClinicalTrials.gov ID
- NCT07662642
- Acronym / sponsor ID
- ROBPROREC1 / ROBPROREC1
- Conditions
- Robotic Surgery, Urologic Surgical Procedures, Postoperative Pulmonary Complications (PPCs), Pulmonary Atelectasis, Postoperative Complications
- Keywords
- Robotic prostate surgery, Recruitment maneuver, Pneumoperitoneum, Trendelenburg position, Positive end-expiratory pressure, Atelectasis, Postoperative pulmonary complications, General anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 9 May 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine Recruitment Group | Experimental | Procedure: Recruitment maneuver in the supine positionAfter 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. |
| Trendelenburg Recruitment Group | Active comparator | Procedure: Recruitment maneuver after insufflation and Trendelenburg positioningAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Age younger than 18 years
- Emergency surgery
- Preoperative oxygen requirement
- Cognitive impairment
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruitment maneuver after insufflation and Trendelenburg positioningA lung recruitment maneuver will be applied after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination using decremental PEEP titration. | Procedure or surgery | Trendelenburg Recruitment Group |
| Recruitment maneuver in the supine positionThe 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. | Procedure or surgery | Supine Recruitment Group |
Primary outcome
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.
1 secondary outcome
Length of hospital stay
Time frame: From the day of surgery to hospital discharge, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 20150855Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24.
- Background: PubMed 32207048Sumer 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.
- Background: PubMed 21068660Futier 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.
- Online ARISCAT score calculator used for preoperative estimation of postoperative pulmonary complication risk in surgical patients.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data privacy regulations and participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment maneuver after insufflation and Trendelenburg positioning and Recruitment maneuver in the supine position in people with Robotic Surgery and Urologic Surgical Procedures, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complications (time frame: From the end of surgery to postoperative 72 hours or until hospital discharge, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07662642, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.