Prostate CancerUltralowNCT03630393
Ultralow Versus Standard Pneumoperitoneum Pressure
A study testing Pneumoperitoneum Pressure 6 mmHg and Pneumoperitoneum Pressure 15 mmHg in people with Prostate Cancer, run by OhioHealth at 1 site in United States.
Trial summary
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pneumoperitoneum Pressure 6 mmHg and Pneumoperitoneum Pressure 15 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Diagnosed with prostate cancer
- Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Who cannot join
- Age < 18
- Emergency surgery
- Patients with a significant preoperative dependence on narcotic medications
- Unable to give informed consent
- Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
- Non-English-speaking or reading
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.
Read the detailed description
The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.
- Conditions
- Prostate Cancer
- Being tested
- Pneumoperitoneum Pressure 6 mmHg, Pneumoperitoneum Pressure 15 mmHg
- Keywords
- Prostatectomy, Robotic, Urology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum Pressure 6 mmHgOther
A pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
Pneumoperitoneum Pressure 15 mmHgOther
A pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP).
| Study group | Role | What they receive |
|---|---|---|
| Pressure 6 mmHg | Experimental | Pneumoperitoneum Pressure 6 mmHg Receives: Other: Pneumoperitoneum Pressure 6 mmHg |
| Pressure 15 mmHg | Active comparator | Pneumoperitoneum Pressure 15 mmHg Receives: Other: Pneumoperitoneum Pressure 15 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Medication Use
The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.
Measured: Through 1 week postoperatively
Secondary outcomes (3)
Post Operative Pain Scores
Each participant was asked to rate their pain on a 0-10 scale, with higher numbers representing worse pain. Patients rated their pain at the following time points: in the post-anesthesia care unit (PACU) upon waking from anesthesia, at hours 4, 12, 16, and 20 after transfer to the floor, and immediately prior to discharge. The pain scores for each patient were averaged.
Measured: Through discharge (post-operative day 0 or post-operative day 1)
Operative Ventilation
Average tidal volume (ml)
Measured: Intraoperatively
Discharge Day (Post-operative Day 0 or 1)
The day of discharge (post-operative day 0 or post-operative day 1) was recorded for each participant
Measured: Through discharge (post-operative day 0 or 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start9 May 2019
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Sponsor
- Investigators
- Ronney Abaza, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630393
- Sponsor's protocol ID
- 1306218
- Acronym
- Ultralow
- Status last verified
- Feb 2022
- First submitted
- 10 Aug 2018
- Last updated
- 18 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
- ClinicalTrials.gov ID
- NCT03630393
- Acronym / sponsor ID
- Ultralow / 1306218
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy, Robotic, Urology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 170 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- 9 May 2019 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.
Detailed description
The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure 6 mmHg | Experimental | Other: Pneumoperitoneum Pressure 6 mmHgPneumoperitoneum Pressure 6 mmHg |
| Pressure 15 mmHg | Active comparator | Other: Pneumoperitoneum Pressure 15 mmHgPneumoperitoneum Pressure 15 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Diagnosed with prostate cancer
- Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)
Key exclusion criteria (7 listed)
- Age < 18
- Emergency surgery
- Patients with a significant preoperative dependence on narcotic medications
- Unable to give informed consent
- Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
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 |
|---|---|---|
| Pneumoperitoneum Pressure 6 mmHgA pneumoperitoneum insufflation pressure of 6 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP). | Other | Pressure 6 mmHg |
| Pneumoperitoneum Pressure 15 mmHgA pneumoperitoneum insufflation pressure of 15 mmHg will be used during robotic assisted laparoscopic prostatectomy (RALP). | Other | Pressure 15 mmHg |
Primary outcome
Postoperative Pain Medication Use
Time frame: Through 1 week postoperatively
The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.
3 secondary outcomes
Post Operative Pain Scores
Time frame: Through discharge (post-operative day 0 or post-operative day 1)
Operative Ventilation
Time frame: Intraoperatively
Discharge Day (Post-operative Day 0 or 1)
Time frame: Through discharge (post-operative day 0 or 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ronney Abaza, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumoperitoneum Pressure 6 mmHg and Pneumoperitoneum Pressure 15 mmHg in people with Prostate Cancer, run by OhioHealth at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Feb 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain Medication Use (time frame: Through 1 week postoperatively). 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 18 Feb 2022.