Not yet recruitingNAINTERVENTIONAL

Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial

This study, called 'RALP', is exploring ways to reduce pain for men having robotic surgery for prostate cancer. During this surgery, doctors inflate the tummy with gas to get a clear view. The amount of pressure from this gas can cause discomfort. This research compares two types of gas-delivery machines (called insufflators) already used in hospitals to see if one leads to less pain during and after the operation. Researchers at Lister Hospital, Stevenage, will study 40 men undergoing prostate removal. They will collect information on pain levels, medication use, and recovery, to help plan bigger studies in the future and hopefully improve patient comfort.

At a glance

Status

Not yet recruiting

Phase

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

Start

01 Apr 2025

Estimated completion

01 Jul 2025

Prostate Cancer (Adenocarcinoma)Prostate Cancer (Post Prostatectomy)Prostate Cancer Surgery Prostate Cancers Prostate Neoplasm Prostatectomy

What is this study about?

When you have robotic surgery for prostate cancer, the surgeon removes your prostate gland. To do this safely and effectively, they need to inflate your tummy with carbon dioxide gas. This creates a clear space for them to see and work. However, the pressure from this gas can sometimes contribute to pain both during and after the operation. Different machines can be used to control this gas pressure. This study wants to find out if one common type of machine causes less pain than another.

Researchers are comparing two specific machines, both of which are already used in NHS hospitals: the 'Conventional Insufflator System' (CIS) and the 'AIRSEAL® Insufflation System' (AIS). They believe that the type of machine used might make a difference to how much pain you feel during and after your surgery. By studying this, they hope to make prostate cancer surgery more comfortable for patients.

This is a 'feasibility' study, which means it's a smaller, early-stage trial. It will involve 40 men having prostate surgery at the Lister Hospital in Stevenage. The main goal is to figure out the best way to run a much larger study in the future. The results from this small study will help them design that bigger trial, which could eventually lead to changes that reduce pain for many more patients.

Key takeaways

This study compares two common surgical machines (insufflators) to see which might cause less pain during prostate cancer surgery.
It's a small, early-stage study to help plan a larger research project.
The study involves 40 men having robotic prostatectomy at Lister Hospital.
Information on pain, recovery, and medication use will be collected for 30 days after surgery.
Participation helps improve comfort for future prostate cancer patients.

Who may be eligible?

This study is looking for men aged between 18 and 75 who are having routine robotic surgery to remove their prostate because of prostate cancer. You need to be able to understand the study and agree to take part.

There are several reasons why you might not be able to join. For example, if you've recently been part of another clinical study, or if you need other surgery at the same time as your prostate removal. Also, if you have certain existing health conditions, like very high blood pressure or diabetes that isn't under control, significant kidney problems, or certain autoimmune diseases, you might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man between 18 and 75 years old?
Are you scheduled for robotic prostatectomy for prostate cancer?
Can you understand the study information and agree to take part?
Do you have any major uncontrolled health conditions like very high blood pressure or diabetes?
Have you recently been part of another medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to have one of the two types of gas-delivery machines used during your prostate surgery. The surgery itself will be the same as planned. After your operation, the research team will collect information about your pain levels, how much pain medication you need, and how quickly you recover in the hospital. They will also look at how long your surgery takes, how long you stay in the recovery room, and if you experience any sickness or other effects after the operation. This information will be collected for 30 days after your surgery, likely through your medical records and possibly some questions you're asked.

Potential risks and benefits

The main potential benefit of this study is helping researchers understand how to reduce pain for men undergoing prostate cancer surgery in the future. While you might not directly benefit from being in this study, your participation helps improve care for others. The risks involved are generally low, as both gas-delivery machines are already commonly used in hospitals. You will have a standard prostatectomy operation. As with any medical study, you are free to withdraw at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Lister hospital
Verified postcode
Stevenage, United Kingdom

Common questions

What is a robotic prostatectomy?

It's a type of surgery where a surgeon uses robotic tools to remove the prostate gland to treat prostate cancer.

What is an insufflator?

It's a medical device used during surgery to gently inflate the abdomen with gas, creating space for the surgeon to see and work better.

Will I know which machine is being used for me?

Participants are randomly assigned to one of the two machines, so you might not know which one is used until part of the study is completed due to the design of the trial.

Is this a new type of operation?

No, the surgery itself is a standard robotic prostatectomy. The study is only looking at different pieces of equipment used during the operation.

What happens if I change my mind?

You are free to leave the study at any point without it affecting your medical care.

How to find out more

Nikhil Vasdev

nikhil.vasdev@nhs.net 07786657541 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.