RecruitingOBSERVATIONAL

Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

If you've had your spleen removed during surgery for peritoneal cancer, this study is about understanding infections that can happen afterwards. Your spleen helps fight off germs, so after it's removed, there's a risk of certain infections. You'll likely receive vaccinations and antibiotics to help prevent these. We want to find out how often these infections occur and if the antibiotics are really useful. This is an observational study, meaning we won't give you any new treatments. Instead, a nurse will call you at set times over five years to ask about your health and how you're feeling. Each call will take less than 20 minutes, and you can stop participating at any time.

At a glance

Status

Recruiting

Sponsor

Hampshire Hospitals NHS Foundation Trust

Enrolment target

300

Start

25 Mar 2021

Estimated completion

01 Feb 2031

Infection;Post Surg Procedure Peritoneal Cancer

What is this study about?

This study focuses on people who have had their spleen removed as part of surgery for a type of cancer that affects the lining of the tummy, called peritoneal cancer. Your spleen is an important organ that helps fight off infections, especially certain kinds of bacteria. When it's removed, there's a higher chance of developing serious infections, sometimes called "overwhelming post-splenectomy infections" (OPSI).

To lower this risk, patients usually get special vaccinations and are often given antibiotics to take regularly after surgery. However, we're not entirely sure how helpful these routine antibiotics are in preventing infections, and antibiotics can sometimes have their own side effects or lead to other problems. This study aims to understand how often these infections actually happen after spleen removal surgery and to see if patients are taking their antibiotics as prescribed. By understanding this better, we hope to improve care for future patients.

This is an "observational study," which means we will simply be gathering information about what happens naturally. You won't be given any new medicines or treatments as part of the study itself. We'll collect information from you through phone calls over a period of five years after your surgery.

Key takeaways

This study is for people who had their spleen removed during peritoneal cancer surgery.
It aims to understand infections after spleen removal and antibiotic use.
Participation involves phone calls over five years, lasting less than 20 minutes each.
You won't receive new treatments; it's an observational study.
Your involvement helps improve future patient care.
You can stop participating at any time.

Who may be eligible?

You might be able to join this study if you are between 18 and 79 years old and have recently had your spleen removed as part of surgery for peritoneal cancer. It's important that you are able to understand what the study involves and are happy to agree to take part.

However, you won't be able to join if you are under 18 or over 79. You also cannot take part if you are taking medications that weaken your immune system. Those who cannot give their informed consent will also not be able to participate.

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 between 18 and 79 years old?
Have you recently had your spleen removed during surgery for peritoneal cancer?
Are you able to understand and agree to take part in the study?
Are you NOT currently taking medication that weakens your immune system?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will last for five years after your surgery. A research nurse will call you over the phone at specific times: at 6 months, 12 months, and then once a year for the next four years. These calls are in addition to any routine calls you'd already be getting from your clinical nurse specialist at 1, 6, and 12 weeks after surgery. Each call from the research nurse will involve answering a questionnaire about your health and will take no more than 20 minutes. At the start of each call, the nurse will confirm you're still happy to participate.

Potential risks and benefits

Taking part in this study won't directly improve your health, as you won't receive any new treatments. However, the information we gather will be very valuable in helping doctors understand more about infections after spleen removal, which could lead to better care for future patients. There are very few risks involved, mainly the time taken for the phone calls. Your information will be kept confidential. Remember, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

The Peritoneal Malignancy Institute, Hampshire Hospitals NHS Foundation Trust
Verified postcode
Basingstoke, United Kingdom· Recruiting

Common questions

What is peritoneal cancer?

Peritoneal cancer is a rare cancer that starts in the peritoneum, which is the lining of your tummy area.

Why do some people have their spleen removed for this cancer?

Sometimes, the spleen might be removed if the cancer has spread to it or if removing it helps the surgeon remove all the cancer affecting the tummy lining.

What are "overwhelming post-splenectomy infections" (OPSI)?

OPSI are serious infections that can occur in people who have had their spleen removed, because the spleen plays a big role in fighting off certain types of bacteria.

Will I have to travel for this study?

No, all participation in this study is done over the phone, so you won't need to visit the hospital specifically for the study.

What if I feel unwell during the study?

This study is just about gathering information. If you feel unwell at any time, you should contact your own doctor or medical team as you usually would.

How to find out more

Victoria Corner

victoria.corner@hhft.nhs.uk 01962 824127 Official trial record

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