Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - "The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg"
Trial ID: NCT06915909
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-04-01
Completion date: 2025-07-01
Sponsor: East and North Hertfordshire NHS Trust
Conditions: Prostate Cancer (Adenocarcinoma); Prostate Cancer (Post Prostatectomy); Prostate Cancer Surgery; Prostate Cancers; Prostate Neoplasm; Prostatectomy
Interventions: surgery
Locations: Lister hospital
Countries: United Kingdom
Enrollment: 40
Age range: 18 Years - 75 Years
Sex: MALE

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* Patient indicated for non-emergent robotic Prostatectomy surgery
* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study
* Males, aged 18 to 75 years
* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioural recommendations and office visits
* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);

Exclusion Criteria:

* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);
* Patients requiring any surgical procedure in addition to Prostatectomy and or / Pelvic Lymph node dissection
* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity
* Inability to provide informed consent
* Unable or unwilling to attend follow-up visits and examinations
* Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL)
* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV
* History of chronic alcohol or drug abuse within 2 years of the screening visit
* Chronic renal failure or on dialysis
* Significant complicating medical history or immunocompromised
* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma
* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
* Any medical condition which precludes compliance with the study
* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure.
* Previous or current history of being on regular analgesia / pain killers

Outcomes:
Recruitment rates; 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.; Pre-op vitals; Pre-op BMI (height and weight); Pre-op labs; Insufflation Pressure; Estimated blood loss; Blood transfusion; Procedure time (initial incision to closure); Surgeon-determined need to increase IAP beyond "study pressure"; Administration of transversus abdominis plane block; Anesthetic/pain medication administration; MedaSense PMD-200 monitor for pain documentation; Intraoperative Peak Airway Pressure every 15 minutes; Intraoperative End Tidal Carbon Dioxide (ETCO2) every 15 minutes; Time in recovery room; Post-op pain incidence and severity; Post-op analgesia usage; Post- op labs as per standard of care; Vital signs 24 hr; Presence or absence of postoperative nausea or vomiting; Length of hospital stay; Any complications that were observed. Post-operative complications through 30 days, reported using Clavien-Dindo Classification, including 30-day mortality; Return to operating room within 24 hour; Readmission to hospital within 30 days; All Adverse Events (intra-operative and post-operative through 30 days)