Prostate Cancer (CRPC)NCT07262073
Comparison of Peak Expiratory Flow Changes After Robot-Assisted Versus Open Radical Prostatectomy
A study testing Surgical procedure: Robot-assisted laparoscopic radical prostatectomy in people with Prostate Cancer (CRPC) and Peak Expiratory Flow, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer (CRPC), Peak Expiratory Flow
- What is being tested?
- Surgical procedure: Robot-assisted laparoscopic radical prostatectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Jun 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Department of Anesthesiology
Ankara, Çankaya
About this study
Official title: 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.
- Conditions
- Prostate Cancer (CRPC), Peak Expiratory Flow
- Being tested
- Surgical procedure: Robot-assisted laparoscopic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure: Robot-assisted laparoscopic radical prostatectomyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Radical Prostatectomy (Control Group) | Active comparator | Patients undergoing open radical prostatectomy under standardized general anesthesia. No pneumoperitoneum or steep Trendelenburg position is applied. Receives: Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy |
| Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group) | Experimental | Patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) under standardized general anesthesia, with carbon dioxide pneumoperitoneum and Trendelenburg positioning. Receives: Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PEF (L/min)
Difference between preoperative and early postoperative PEF values.
Measured: From preoperative baseline to postoperative 2nd hour
Secondary outcomes (3)
Change in PEF from preoperative to postoperative 24th hour
Evaluates recovery of PEF compared to baseline.
Measured: From preoperative measurement (baseline) to postoperative 24th hour
Intraoperative parameters correlated with PEF reduction
Correlation between PEF change and intraoperative variables including Trendelenburg angle/duration, pneumoperitoneum pressure/duration, ventilatory pressures, and intraoperative fluid balance.
Measured: From induction of anesthesia to end of surgery
Incidence of respiratory complications
Frequency of postoperative respiratory events such as desaturation, need for reintubation, or presence of chemosis.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Nov 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
- Investigators
- betül aytaç, Principal investigator, Ankara Bilkent City Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262073
- Sponsor's protocol ID
- TABED1-25-1680
- Status last verified
- Oct 2025
- First submitted
- 23 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study Comparing Peak Expiratory Flow (PEF) Changes After Robot-Assisted and Open Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07262073
- Acronym / sponsor ID
- TABED1-25-1680
- Conditions
- Prostate Cancer (CRPC), Peak Expiratory Flow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Radical Prostatectomy (Control Group) | Active comparator | Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomyPatients undergoing open radical prostatectomy under standardized general anesthesia. No pneumoperitoneum or steep Trendelenburg position is applied. |
| Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group) | Experimental | Diagnostic Test: Surgical procedure: Robot-assisted laparoscopic radical prostatectomyPatients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP) under standardized general anesthesia, with carbon dioxide pneumoperitoneum and Trendelenburg positioning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Moderate/severe COPD (GOLD II-IV)
- Active upper respiratory tract infection
- Severe OSA requiring CPAP
- Inability to perform standardized PEF maneuver
- Emergency surgery
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 |
|---|---|---|
| Surgical procedure: Robot-assisted laparoscopic radical prostatectomyRALRP 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. | Diagnostic test | Open Radical Prostatectomy (Control Group), Robot-Assisted Laparoscopic Radical Prostatectomy (Study Group) |
Primary outcome
Change in PEF (L/min)
Time frame: From preoperative baseline to postoperative 2nd hour
Difference between preoperative and early postoperative PEF values.
3 secondary outcomes
Change in PEF from preoperative to postoperative 24th hour
Time frame: From preoperative measurement (baseline) to postoperative 24th hour
Intraoperative parameters correlated with PEF reduction
Time frame: From induction of anesthesia to end of surgery
Incidence of respiratory complications
Time frame: Within the first 24 hours after surgery
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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
betül aytaç principal investigator
Ankara Bilkent City Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure: Robot-assisted laparoscopic radical prostatectomy in people with Prostate Cancer (CRPC) and Peak Expiratory Flow, run by Ankara City Hospital Bilkent 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PEF (L/min) (time frame: From preoperative baseline to postoperative 2nd hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.