Clinical Trial

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

Study acronym: ICE
Recruiting
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Summary
Endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility. Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). To reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. These stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. Squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). Before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-02-24; most recent amendment 2025-08-26.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT06852248
Lead Sponsor University Hospitals of North Midlands NHS Trust
Conditions Endometriosis, Deep Endometriosis
Enrollment 70 participants
Start Date 2025-07-29
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-03