NCT06915909Recruiting
Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial
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"
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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. An amendment has been approved to recruit an additional 60 participants, total overall recruitment is 100.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Feb 2025
- Start date
- 22 Apr 2025
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Diseases
- Prostate cancer
- NCT number
- NCT06915909
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 22 Apr 2025 to the primary completion date, 17 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous or current history of being on regular analgesia / pain killers
Other illness
- History of chronic alcohol or drug abuse within 2 years of the screening visit
- Chronic renal failure or on dialysis
- 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.
Lab values
- Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL)
Other
- Inability to provide informed consent
- Unable or unwilling to attend follow-up visits and examinations
- Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV
- Significant complicating medical history or immunocompromised
Who the study is looking for
- 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);
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lister Hospital Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.