University Hospitals of North Midlands has secured £250,000 from NIHR to run the ICE trial, a two‑year feasibility study testing a novel dye method to improve surgical outcomes in endometriosis
The University Hospitals of North Midlands (UHNM) has secured £250,000 in government funding to launch an innovative clinical trial focused on improving care for people with endometriosis. In partnership with Birmingham Women’s and Children’s NHS Foundation Trust, the two-year study will explore whether a novel dye technique can enhance surgical precision, reduce complications, and improve outcomes for patients undergoing treatment for this often-debilitating condition.
Improving outcomes for women with endometriosis
Endometriosis is a condition where cells similar to those in the lining of the womb grow in other parts of the body. It is a common yet debilitating condition and often causes severe pelvic pain and infertility. Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes (ureters) that drain urine from the kidneys to the bladder. To reduce this risk, surgeons may put tiny plastic tubes called “stents“ inside the ureters. These stents stay for 2-4 weeks following surgery, but can cause considerable pain and blood in the urine.
To improve surgical outcomes for endometriosis patients, UHNM will conduct the ‘ICE trial’, following investment from the NIHR Research for Patient Benefit Programme, one of the UK’s most competitive research funding streams.
The trial will compare the standard stent method with a novel technique using indocyanine green (ICG) dye. Instead of inserting long stents, a small catheter delivers the dye into the ureters, which can then be seen under special light during surgery. This approach may significantly reduce patients’ pain, surgical complications, and recovery time. The trial will be delivered in partnership with Birmingham Women’s and Children’s NHS Foundation Trust.
Surgeons lead innovative trial comparing dye-based technique to traditional stenting in complex surgery
Mr Gourab Misra, consultant gynaecologist at UHNM and chief investigator, said: “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, to launch 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.”
Mr Misra added: “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.”
Professor Justin Clark, Consultant Gynaecologist who is leading on the study at Birmingham Women’s and Children’s NHS Foundation Trust, said: “Deep endometriosis affects and causes significant pain adversely affecting quality of life. Whilst surgery is effective, it is highly complex. This trial uses a novel dye called ICG that identifies the ureters, which are pipes that transport urine from the kidney to the bladder. We hope that this study will show that using ICG can reduce complications, speed up surgery, and reduce pain following the operation, as well as enhance recovery.”
