RecruitingNAINTERVENTIONAL

MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.

The MIRRORS-FROZEN study is looking at the best way to treat complex growths on the ovaries or fallopian tubes, called adnexal masses, that are 8cm or smaller. These growths can sometimes be early cancer. Currently, doctors often use standard open surgery, which involves a larger cut and can mean a longer, more painful recovery. Robotic surgery, which uses smaller cuts, has shown quicker recovery for other conditions. This study compares robotic surgery with open surgery to see if robotic surgery can lead to better outcomes for patients, particularly by helping those with non-cancerous or slow-growing masses avoid a big operation, and by understanding its effects if cancer is found. It's a pilot study to see if a larger trial should be done.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Enrolment target

Start

23 Sep 2024

Estimated completion

01 Feb 2027

Ovarian Cancer Ovarian Mass Ovarian Cysts Fallopian Tube Neoplasms Adnexal Carcinoma Adnexal Cyst Adnexal Masses

What is this study about?

Growths can sometimes appear on or near your ovaries or fallopian tubes. Doctors call these 'adnexal masses' or 'complex pelvic masses'. They can happen for many reasons, like hormone changes or infection, and sometimes they might be an early sign of cancer. You might not have any symptoms, or you could feel discomfort, pain, or constipation. When these are seen on scans, sometimes the word "complex" is used, which means they need a closer look, as there's a chance they could be early-stage cancer.

Usually, such growths are removed with surgery. Doctors often use standard open surgery, which means a larger cut is made from your belly button down to your pubic bone. During the operation, a small piece of the growth is checked under a microscope to find out if it's cancer. If it is cancer, more surgery might be needed to check if it has spread. Recovery from this type of open surgery can be a bit long and can involve pain. However, we know that many of these growths turn out not to be cancer or are a very slow-growing type.

This study, called MIRRORS-FROZEN, is trying to find out if robotic surgery could be a better option for removing these types of complex growths when they are 8 centimetres or smaller. Robotic surgery involves smaller cuts, and for other conditions, it has been shown to lead to a quicker recovery, less pain, and less blood loss. The main goal of this pilot study is to see if it's practical to do a bigger study later on. It will compare robotic surgery to standard open surgery, hoping that more patients with non-cancerous or slow-growing growths can avoid the bigger open surgery. It will also help us understand how robotic surgery compares for patients where cancer is found.

Key takeaways

The study compares open surgery and robotic surgery for complex growths on ovaries/fallopian tubes.
It's for growths 8cm or smaller which might be early cancer.
Robotic surgery generally involves smaller cuts and quicker recovery.
The study aims to see if robotic surgery is a better option for these conditions.
It's a small initial study to see if a larger research project should be done later.

Who may be eligible?

This study is looking for women aged 18 to 100 years old. To be part of it, you need to have a complex growth (adnexal mass) in your pelvis, on or near your ovaries or fallopian tubes, that is 8 centimetres or smaller. Importantly, scans (like CT or MRI) must not show any signs that cancer has spread outside of this area.

You cannot join the study if your growth is larger than 8 centimetres, or if scans or other tests already show that you have a more advanced stage of cancer (stage III or IV). You also need to be able to understand what the study involves and agree to take part. If you're not suitable for keyhole surgery (for example, if you have certain heart conditions), you won't be able to participate. If you do join the study and doctors later find your cancer is more advanced than first thought, you would stop participating in the study and receive treatment according to standard national guidelines.

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 woman between 18 and 100 years old?
Do you have a complex growth (adnexal mass) on your ovary or fallopian tube?
Is your growth 8 centimetres or smaller?
Do scans show no signs of cancer spreading outside that area?
Are you able to understand the study and give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the MIRRORS-FROZEN study, you would first have detailed discussions with the study team and receive information to help you understand everything. If you agree, you'll sign a consent form. While the full list of visits and assessments isn't provided, you would undergo either standard open surgery or robotic surgery, decided by chance (like flipping a coin). This is done so researchers can fairly compare both approaches.

After your surgery, the study will collect information about how you recover, any pain you might have, and how quickly you return to your daily activities. They will also look at how effective the surgery was and check for any cancer outcomes. You might also be asked to fill out questionnaires about your well-being (patient-reported outcomes).

The study is a pilot, meaning it's a smaller first step to see if a larger study is possible. Therefore, the exact total duration of your involvement could vary, but it would involve the surgery itself and follow-up to collect important health information afterwards.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that if you are assigned to robotic surgery, you might experience a quicker recovery with less pain and blood loss compared to traditional open surgery. The study also aims to improve treatment options for women with these types of growths in the future. However, there are also risks associated with any surgery, including infection, bleeding, or complications from anaesthesia, regardless of whether it's open or robotic surgery. This study is designed to compare two established surgical methods. You have the right to withdraw from the study 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.

The Royal Surrey County Hospital NHS Foundation Trust.
Verified postcode
Guildford, United Kingdom· Recruiting

Common questions

What is an adnexal mass?

It's a growth that forms on or near your ovaries or fallopian tubes. It can be non-cancerous, slow-growing, or sometimes an early sign of cancer.

What's the difference between open and robotic surgery?

Open surgery involves a larger cut (incision) in your tummy. Robotic surgery uses special instruments and smaller cuts, often leading to quicker recovery and less pain.

Why is this study only for growths 8cm or smaller?

The study focuses on smaller growths because these are the ones where robotic surgery is most likely to be a suitable option to compare with open surgery.

What if cancer is found during the study?

If you are found to have advanced cancer, you will stop participating in the study and your doctors will treat you according to the standard national guidelines for cancer care.

Who is funding this research?

The MIRRORS-FROZEN study is funded by the Intuitive Foundation and GRACE Charity.

How to find out more

Radwa Hablase, MBBCh MRCOG PGCert

r.hablase@nhs.net +441483688660 Official trial record

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