Robotic Prostatectomy AI low pressure pain study
Research type
Research Study
Full title
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”.
IRAS ID
346481
Contact name
Nikhil Vasdev
Contact email
Sponsor organisation
East and North Hertfordshire NHS Trust
Duration of Study in the UK
4 years, 0 months, 23 days
Research 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 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.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0019
Date of REC Opinion
27 Jan 2025
REC opinion
Further Information Favourable Opinion