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Hear from your clinical team

Deep endometriosis (DE) is a common condition affecting one in 10 women, which can cause severe pain. It happens when cells similar to those lining the womb grow outside it, generally on surfaces and organs within the pelvic cavity, causing bleeding, scarring and inflammation.

Occasionally, rather than growing on or very near the surface, the endometriosis cells can grow deeper into tissues and organs, such as the bowel, bladder and the vagina causing a painful condition which used to be known as “deep infiltrating endometriosis” and is now called deep endometriosis. DE is treated by using keyhole (laparoscopic) surgery to remove areas of endometriosis.

ICE is a research study to compare surgery using traditional technique stents or a new technique dye for women with deep endometriosis.

The study is funded by the National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB). 

Hear from the team:

 

 Introduction to ICE trial:

“Surgery for deep endometriosis is complex and carries a risk of damaging the ureters, the delicate tubes connecting the kidneys to the bladder. Traditionally, surgeons use stents to identify and protect these structures, but these can cause significant pain, bleeding, and require a second procedure to remove.
 
“As a group of surgeons, we saw the challenges our patients faced and worked hard to design this proposal. Our aim is to minimise complications and improve the patient journey, reducing pain and morbidity associated with these complex procedures.
 
“The trial will recruit 70 patients across the two sites over two years, randomising them to receive either conventional stenting or the dye-based technique. It is designed to test feasibility, including whether patients and surgeons are willing to participate, with a view to launching a future full-scale randomised trial that could see the technique adopted across the NHS and globally.
 
“It’s been a real team effort. We want to thank our colleagues at Birmingham Women’s and Children’s, Keele University, our anaesthetic teams, and the research and innovation teams at both sites. Most importantly, we’re grateful to our patients who helped us shape this study by sharing their experiences.”
 

“This is a trial we’re passionate about because it has real potential to change how we do this surgery, both here at UHNM and internationally. It’s about giving our patients the best possible experience and outcomes.”

- Mr Gourab Misra, consultant gynaecologist at UHNM and chief investigator

 

 

“If you’re undergoing surgery for deep endometriosis, you may be eligible to take part in the ICE trial. This study explores a new way to help surgeons see and protect the ureters—the tubes that drain urine from the kidneys—during surgery.

Currently, surgeons use small plastic tubes called ‘stents’ to make the ureters more visible, but these can sometimes cause discomfort. The ICE trial is testing a special dye called IndoCyanine Green (ICG) as an alternative, which may reduce post-operative pain while maintaining safety.

If you choose to take part, you’ll be randomly assigned to either the standard stent method or the new dye technique during your surgery. Your care and recovery will remain the same, and we’ll follow up with you to understand your experience. In addition to routine post-operative follow up with your surgical team, you will be asked to complete questionnaires measuring pain and your quality of life at 6 and 12 weeks following your operation.

Taking part is completely voluntary. Your decision won’t affect your care, and you can withdraw at any time. If you’d like to learn more, speak to your doctor or our research team. Your participation could help improve future care for women with deep endometriosis.

Thank you for considering the ICE trial.”

Day surgery overview:

" Hello, my name is Tom Coia and in this short video I am to show you what you can expect on the day of surgery if you choose to participate in the ICE trial.

This video has been made for patients considering participating in, or who have already been recruited to, the ICE trial.  Equally, some of the information contained within this video may be relevant to friends and relatives of those considering participation in this study.

If you do choose to participate in this trial, on the day of your surgery you will be admitted to the surgical ward.  Routine observations will be taken, including your pulse, and your blood pressure.  You will be asked to provide a specimen of urine so as a urine pregnancy test can be performed.  You will be seen by your surgical team before your operation, this is an excellent time to ask any lastminute questions about the procedure that is about to start.  You will also have an opportunity to meet the anaesthetic team.  We will confirm your consent and your willingness to participate in this study. 

Your journey to theatre will start with you being collected from the pre-op ward.  At multiple points on your journey to theatre your ID will be checked with yourself and against the wristband that you will be wearing.  Again, at multiple points, people will check your consent form and ensure you have been properly consented for the procedure that is about to take place.  After your operation you will be moved to the theatre recovery area.  Here the staffing levels are very high, so as your requirements for pain relief can be catered to very quickly.  When you are fit to leave recovery, you’ll be moved to a post-operative ward.  On the post-op ward, you would be expected to be seen by a member of your surgical team to explain the procedure that has just taken place. 

Pain and nausea are unfortunately very common after any surgical procedure, but rest assured we will do our best to keep this to an absolute minimum.  It is very likely you will wake up with a urinary catheter in place.  This collects urine from the bladder.  We will aim to remove this as soon as it is practical and safe to do so.  Straight away after your operation we are working on getting you home as soon as you feel well enough and it’s safe to do so.  Follow up will be put in place that is necessary for this trial and for your clinical needs.  Blood thinners are often given after laparoscopic surgical procedures.  These are small injections that aim to reduce the risk of blood clots forming in the legs and the lungs.  If you require these, you will be told and you will also be shown how to give them. 

I hope this video has given you some idea what you can expect on the day of surgery should you choose to participate in the ICE trial.  If you still have questions, please do feel free to get in touch with any member of the trial team and we will so our best to answer these as soon as possible.  Thank you."

"If you take part in the study, you will have routine clinical follow up with your endometriosis team but in addition they will ask you to complete questionnaires at 6 and 12 weeks asking about how your operation has affected your pain, quality of life and if you have suffered any complications. We hope you will agree to take part in this trial and attend all follow up appointments".