RecruitingOBSERVATIONAL

Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery

This study is investigating a new method to help surgeons identify and protect the tubes that carry urine from your kidneys to your bladder (ureters) during surgery for deep endometriosis. Currently, doctors often use small plastic tubes called stents inside the ureters. While these reduce the risk of damage, they can be painful and cause blood in the urine for up to four weeks after surgery. This trial is exploring whether using a special dye, called indocyanine green, instead of stents, could make surgery safer and lead to less pain for patients afterwards. It's a first step to see if this new approach is practical and won't make the surgery longer or increase other complications.

At a glance

Status

Recruiting

Sponsor

University Hospitals of North Midlands NHS Trust

Enrolment target

Start

29 Jul 2025

Estimated completion

01 Mar 2028

Endometriosis Deep Endometriosis

What is this study about?

Endometriosis is a common condition where tissue similar to the lining of the womb grows outside of it, often in the pelvis. For some women, this can cause a lot of pain and even make it harder to get pregnant. If the endometriosis is very deep and causing severe problems, surgery might be needed to remove it.

During this surgery, there's a small risk of accidentally damaging the ureters – these are the important tubes that connect your kidneys to your bladder and carry urine. To help prevent this, surgeons sometimes put tiny, temporary plastic tubes, called stents, inside the ureters. While stents protect the ureters, they can cause significant pain and sometimes lead to blood in the urine for a few weeks after the operation.

This study is looking at a different way to protect the ureters. Instead of stents, doctors are trying to use a special dye. This dye helps them see the ureters more clearly during surgery. The hope is that this new method will make the procedure just as safe, but with less pain and discomfort for you during your recovery. Before using this widely, doctors need to check if it's a good and safe option.

Key takeaways

This study explores a new way to protect important tubes during deep endometriosis surgery.
It compares using a special dye versus temporary plastic tubes (stents).
The goal is to reduce pain after surgery.
It's an early study to see if the new method is practical and safe.
Participation could help improve future endometriosis care.

Who may be eligible?

This study is for women aged between 18 and 50 years old. You might be able to take part if you are planning to have keyhole surgery (laparoscopic or robotic-assisted) to remove deep endometriosis, and your surgeon expects to use ureteric stents as part of your planned surgery.

There are some reasons why you wouldn't be able to join. For instance, if you are pregnant or think you might be, or if there's any suspicion of cancer. Also, if you've had a ureter injury before, or if you have certain serious health conditions like uncontrolled diabetes, severe lung disease, or certain heart problems, you wouldn't be eligible. Your Body Mass Index (BMI) also needs to be under 45.

Quick self-check

Are you a woman between 18 and 50 years old?
Are you having keyhole surgery for deep endometriosis?
Has your doctor said they would normally use ureteric stents for your surgery?
Are you not pregnant and do not suspect you are?
Do you not have a confirmed or suspected cancer?
Do you not have specific serious health conditions (like uncontrolled diabetes or severe heart/lung problems)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This is a feasibility study, which means it's a small, early study to see if a new method is practical. If you join, you would be having surgery for deep endometriosis as planned. The main difference would be that instead of traditional ureteric stents, the surgical team would use a special dye to help identify your ureters during the operation. The study would involve close monitoring during and after your surgery to compare this new method with the standard approach. This would look at how the surgery went, any complications, and your recovery, especially focusing on pain levels.

Potential risks and benefits

Potential benefits of participating include helping doctors learn if a new method can reduce pain after endometriosis surgery, which could improve care for many women in the future. There's a chance you might experience less post-operative pain if the dye method is successful compared to traditional stents. Potential risks are generally linked to the surgery itself, which your doctor will discuss with you. Any new method in surgery carries potential unforeseen risks, but this study aims to see if the dye is as safe as current practices. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom· Recruiting

Common questions

What is endometriosis?

Endometriosis is a condition where tissue similar to the lining of the womb grows outside of it, often causing pain and other symptoms.

What are ureters?

Ureters are tubes that carry urine from your kidneys to your bladder.

Why is protecting ureters important during surgery?

Protecting ureters during surgery for deep endometriosis is crucial to avoid damaging them, which could lead to serious complications.

What is Indocyanine Green (ICG) dye?

It's a special dye used to help surgeons see body structures more clearly during an operation.

Will my surgery be different if I join this study?

The main difference would be using a special dye to help see your ureters instead of placing temporary plastic tubes (stents) inside them, but the overall surgery for endometriosis would proceed as planned.

How to find out more

Aviva Ogbolosingha

aviva.ogbolosingha@uhnm.nhs.uk 01782675380 Official trial record

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