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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorUniversity Hospitals of North Midlands NHS Trust

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ureteric stenting
  • Indocyanine green (ICG) dye

Treatment groups

70 Participants
are divided into 2 treatment groups