NCT06852248

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

Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery: A Pilot Trial (ICE Trial)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: University Hospitals of North Midlands NHS Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Endometriosis
• Deep Endometriosis

Interventions

Type	Name	Description
PROCEDURE	Ureteric stenting	The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will have conventional ureteric stenting (temporary tubes placed in the ureters)
PROCEDURE	Indocyanine green (ICG) dye	The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.

Timeline

• Start date: 2025-07-29
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2025-02-28
• Last updated: 2025-09-03

Locations

1 site across 1 country: United Kingdom