Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
Recruiting now
Conditions studied: Endometriosis, Deep Endometriosis
In brief
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
Key facts
- Study ID
- NCT06852248
- Run by
- University Hospitals of North Midlands NHS Trust
- People needed
- 70
- Starts
- 2025-07-29
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Confirmed or suspected pregnancy at the time of enrolment.
- Suspicion or confirmation of malignancy.
- History of ureteric injury from prior surgery or trauma
- Medically unfit for surgery due to the following conditions:
- Uncontrolled diabetes mellitus.
- Severe Chronic Obstructive Pulmonary Disease (COPD).
- Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis).
- History of stroke or severe kyphoscoliosis.
- Uncontrolled hypertension.
- Body mass index (BMI): BMI greater than 45
Where it is running
- University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, Staffordshire, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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