The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery. A robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts. 40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.
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Recruitment rates
Timeframe: Through study completion estimated to be 6-12 months
Evaluate treatment-based adverse events, serious adverse events, anticipated adverse device effects, unanticipated adverse device effects and all device deficiencies and use errors, regardless of relationship to an adverse event.
Timeframe: Through study completion estimated to be 6-12 months
Pre-op vitals
Timeframe: Baseline/day 1
Pre-op BMI (height and weight)
Timeframe: Baseline/day 1
Pre-op labs
Timeframe: Baseline/day 1
Insufflation Pressure
Timeframe: Perioperative
Estimated blood loss
Timeframe: Perioperative
Blood transfusion
Timeframe: Perioperative
Procedure time (initial incision to closure)
Timeframe: Perioperative
Surgeon-determined need to increase IAP beyond "study pressure"
Timeframe: Perioperative
Administration of transversus abdominis plane block
Timeframe: Perioperative
Anesthetic/pain medication administration
Timeframe: Perioperative
MedaSense PMD-200 monitor for pain documentation
Timeframe: Perioperative
Intraoperative Peak Airway Pressure every 15 minutes
Timeframe: Perioperative
Intraoperative End Tidal Carbon Dioxide (ETCO2) every 15 minutes
Timeframe: Perioperative
Time in recovery room
Timeframe: Perioperative
Post-op pain incidence and severity
Timeframe: Day 1-30 post-op/post-intervention
Post-op analgesia usage
Timeframe: Day 1-30 post-op/post-intervention
Post- op labs as per standard of care
Timeframe: Day 1-30 post-op/post-intervention
Vital signs 24 hr
Timeframe: Day 1 post-op/post-intervention
Presence or absence of postoperative nausea or vomiting
Timeframe: Day 1 post-op/post-intervention
Length of hospital stay
Timeframe: Day 1-30 post-op/post-intervention
Any complications that were observed. Post-operative complications through 30 days, reported using Clavien-Dindo Classification, including 30-day mortality
Timeframe: Day 1-30 post-op/post-intervention
Return to operating room within 24 hour
Timeframe: Day 1-30 post-op/post-intervention
Readmission to hospital within 30 days
Timeframe: Day 1-30 post-op/post-intervention
All Adverse Events (intra-operative and post-operative through 30 days)
Timeframe: Day 1-30 post-op/post-intervention