Obese Patients With Prostate Cancer DiseasePhase 3OPERANCT01868347
Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position
A Phase 3 study testing treatment in people with Obese Patients With Prostate Cancer Disease, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Obese Patients With Prostate Cancer Disease
- What is being tested?
- treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- BMI >= 30
- Robotic-assisted laparoscopic prostatectomy
Who cannot join
- Chronic cardiac or pulmonary diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O.U San Luigi Gonzaga Hospital, Univesity of Turin
Turin, Italy, 10126
Pierpaolo Terragni, MD, +390116334002, pierpaolo.terragni@unito.it
Pierpaolo Terragni, MD
About this study
Official title: The Obese Patient in the Urologic Robotic Surgery: the Role of a Preemptive Ventilator Strategy and Partitioning to Contrast Pneumoperitoneum and Trendelenburg Position
Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.
Read the detailed description
RARP (robotic assisted radical prostatectomy) requires the induction of pneumoperitoneum and the trendelenburg position, causing increase in the intra-abdominal pressure and cephalic shift of the diaphragm, with consequent airway closure and collapse of the dependent regions of the lung.
Obese subjects present an increased risk of respiratory complications, caused not only by the surgical procedure itself, but also by the respiratory mechanics changes associated with the body mass. In obese patients we can observe higher values of lung and chest wall elastance, with reduction in ventilation-perfusion ratio.
The partitioning between lung and chest wall elastance can improve ventilatory setting and mechanics parameters of ventilation.
In every patient we will place, after anesthesia induction, a catheter to get esophageal and gastric pressure that represent pleural and abdominal pressure.
Ventilation will be conducted with a tidal volume of 8-10 ml/kg (IBW) and a respiratory rate adequate to maintain a physiological level of Pa CO2.
The preemptive strategy involves recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position in the treatment group, while the current procedure provides it afterwards (control group).
- Being tested
- treatment, control
- Keywords
- obese patients, specific elastance, Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatmentOther
preemptive PEEP before pneumoperitoneum and trendelenburg
controlOther
PEEP after pneumoperitoneum and trendelenburg
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | PEEP after pneumoperitoneum and trendelenburg Receives: Other: control |
| Treatment | Experimental | preemptive PEEP before pneumoperitoneum and trendelenburg Receives: Other: treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of arterial oxygenation
Measured: at 6 hours (average duration of surgery procedure)
Secondary outcomes (2)
evaluation of specific static elastance of the lung
Evaluation of the elastic properties of the lung (specific static elastance)
Measured: at 6 hours (average duration of surgery procedure)
evaluation of difference between arterial end-tidal partial pressure of carbon dioxide
difference between arterial end-tidal partial pressure of carbon dioxide is an indicator of lung collapse and reopening after open-lung PEEP, which in turn reduce dead space
Measured: at 6 hours (average duration of surgery procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Patients With Prostate Cancer DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PierPaolo Terragni, University of Turin, Italy
- Investigators
- Pierpaolo Terragni, MD, Principal investigator, University of Turin, ItalyAugusto Tempia, MD, Study chair, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868347
- Sponsor's protocol ID
- CEI-20686
- Acronym
- OPERA
- Status last verified
- May 2013
- First submitted
- 23 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Obese Patient in the Urologic Robotic Surgery: the Role of a Preemptive Ventilator Strategy and Partitioning to Contrast Pneumoperitoneum and Trendelenburg Position
- ClinicalTrials.gov ID
- NCT01868347
- Acronym / sponsor ID
- OPERA / CEI-20686
- Keywords
- obese patients, specific elastance, Trendelenburg Position, Pneumoperitoneum, robotic surgery, Prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jun 2013 (estimated)
- 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.
Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.
Detailed description
RARP (robotic assisted radical prostatectomy) requires the induction of pneumoperitoneum and the trendelenburg position, causing increase in the intra-abdominal pressure and cephalic shift of the diaphragm, with consequent airway closure and collapse of the dependent regions of the lung.
Obese subjects present an increased risk of respiratory complications, caused not only by the surgical procedure itself, but also by the respiratory mechanics changes associated with the body mass. In obese patients we can observe higher values of lung and chest wall elastance, with reduction in ventilation-perfusion ratio.
The partitioning between lung and chest wall elastance can improve ventilatory setting and mechanics parameters of ventilation.
In every patient we will place, after anesthesia induction, a catheter to get esophageal and gastric pressure that represent pleural and abdominal pressure.
Ventilation will be conducted with a tidal volume of 8-10 ml/kg (IBW) and a respiratory rate adequate to maintain a physiological level of Pa CO2.
The preemptive strategy involves recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position in the treatment group, while the current procedure provides it afterwards (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: controlPEEP after pneumoperitoneum and trendelenburg |
| Treatment | Experimental | Other: treatmentpreemptive PEEP before pneumoperitoneum and trendelenburg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >= 30
- Robotic-assisted laparoscopic prostatectomy
Key exclusion criteria (1 listed)
- Chronic cardiac or pulmonary diseases
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 |
|---|---|---|
| treatmentpreemptive PEEP before pneumoperitoneum and trendelenburg | Other | Treatment |
| controlPEEP after pneumoperitoneum and trendelenburg | Other | control |
Primary outcome
evaluation of arterial oxygenation
Time frame: at 6 hours (average duration of surgery procedure)
2 secondary outcomes
evaluation of specific static elastance of the lung
Time frame: at 6 hours (average duration of surgery procedure)
evaluation of difference between arterial end-tidal partial pressure of carbon dioxide
Time frame: at 6 hours (average duration of surgery procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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.
A.O.U San Luigi Gonzaga Hospital, Univesity of Turin
Turin, Italy
Pierpaolo Terragni, MD principal investigator
University of Turin, Italy
Augusto Tempia, MD study chair
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing treatment in people with Obese Patients With Prostate Cancer Disease, run by University of Turin, Italy at 1 site in Italy.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2013. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
evaluation of arterial oxygenation (time frame: at 6 hours (average duration of surgery procedure)). 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 6 Jun 2013.