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
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
Confirmed or suspected pregnancy at the time of enrolment.
Suspicion or confirmation of malignancy.
History of ureteric injury from prior surgery or trauma
Uncontrolled diabetes mellitus.
Women with deep endometriosis
Cohort
Prospective
Ureteric stenting
Procedure/SurgeryThe 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)
Indocyanine green (ICG) dye
Procedure/SurgeryThe 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.
Number of eligible women
The number of eligible women across 2 UK sites that are suitable for trial recruitment
Proportion of eligible women agreeing to participate
Number of women who are eligible that then take part in the trial
Attrition rate in follow up process
Recording the percentage of people who drop out before the completion
Missing data in follow up process
Recording how much data is missing from the follow up data
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