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
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Women aged 18 to 50 years

• Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned.

• Willing and able to provide consent for participation in the study

Locations
Other Locations
United Kingdom
University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Contact Information
Primary
Aviva Ogbolosingha
aviva.ogbolosingha@uhnm.nhs.uk
01782675380
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2028-03
Participants
Target number of participants: 70
Treatments
Ureteric stenting
One group will have conventional ureteric stenting (temporary tubes placed in the ureters).
Indocyanine green (ICG) dye
One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.
Related Therapeutic Areas
Sponsors
Leads: University Hospitals of North Midlands NHS Trust

This content was sourced from clinicaltrials.gov