Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku 18-75 lat
- •Czeka na operację usuwania prostaty (nie w trybie nagłym)
- •Zdolny do podpisania zgody na uczestnictwo w badaniu
- •Stan zdrowia pozwala na bezpieczne przeprowadzenie operacji
- •Zdolny do zrozumienia procedury i stosowania się do zaleceń lekarskich
✗ Disqualifies
- •Uczestnictwo w innym badaniu medycznym w ciągu ostatnich 90 dni
- •Wcześniejsza operacja w miednicy lub zabiegi zmniejszające pojemność żołądka
- •Niekontrolowane wysokie ciśnienie krwi (≥180/120) lub cukrzyka (cukier we krwi >200)
- •Przewlekła niewydolność nerek lub dializa
- •Historia uzależnienia od alkoholu lub narkotyków w ostatnich 2 latach
- •Poważne osłabienie odporności lub choroby autoimmunologiczne
- •Niemożność przychodzenia na wizyty kontrolne
- •Inne poważne choroby mogące stanowić zagrożenie dla bezpieczeństwa
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 8, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Lister hospital
Stevenage, United Kingdom
Trial contact
Nikhil Vasdev
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.