Identifying ureters during deep endometriosis surgery using indocyanine green dye instead of ureteric stents
Official title: 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)
Run by University Hospitals of North Midlands NHS Trust · NCT06852248 · Data updated 2026-11-12
This project will see if injecting indocyanine green dye into the ureters causes less postoperative pain than placing ureteric stents for women aged 18–50 undergoing laparoscopic or robotic surgery for deep endometriosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | University Hospitals of North Midlands NHS Trust Academic / other |
| Locations | 1 site (Stoke-on-Trent, Staffordshire) |
| Status | Recruiting |
| Started | July 29, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2028 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06852248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–50 scheduled for laparoscopic or robotic excision of deep endometriosis where ureteric stenting is planned and who are able to give informed consent.
✕Probably not a fit
People who are pregnant, have suspected malignancy, prior ureteric injury, are medically unfit for surgery, or have a BMI over 45 are excluded and unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Surgeons often place temporary ureteric stents during excision of deep endometriosis to reduce the risk of ureteric injury, but stents can cause significant pain and blood in the urine. This observational feasibility project compares conventional ureteric stenting with injection of indocyanine green (ICG) dye to make ureters visible under near-infrared imaging. Investigators will record perioperative outcomes including postoperative pain, urinary symptoms, operative time, and surgical complications to determine whether the dye approach appears safe and acceptable. Results will be used to decide if a larger randomized trial is warranted.
Why it matters
Potential benefit: If successful, this technique could reduce stent-related pain and urinary symptoms after deep endometriosis surgery while keeping similar safety and surgical outcomes.
How similar studies have gone: Small surgical series and case reports have shown ICG can reliably highlight ureters and suggest fewer stent-related symptoms, but randomized or large comparative evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom Recruiting
Study contacts
- Study coordinator: Aviva Ogbolosingha
- Email: aviva.ogbolosingha@uhnm.nhs.uk
- Phone: 01782675380
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Franco-European Institute of Endometriosis long-term outcomes cohort
This cohort will follow women with confirmed pelvic endometriosis to see if different medical and surgical treatments lead to better long-term symptoms, quality of life, recurrence rates, and fertility outcomes.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
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Comparing robotic and laparoscopic surgery for deep endometriosis
This study is testing whether robot-assisted surgery is better than regular laparoscopic surgery for people with deep endometriosis in terms of pain relief and quality of life after the procedure.
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Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
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Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
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Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.